diabetic foot thesis topics

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• Published: 06 August 2022

A qualitative study of barriers to care-seeking for diabetic foot ulceration across multiple levels of the healthcare system

• Tze-Woei Tan   ORCID: orcid.org/0000-0002-6658-9482 1 , 2 ,
• Rebecca M. Crocker 3 ,
• Kelly N. B. Palmer 3 ,
• Chris Gomez 4 ,
• David G. Armstrong 1 , 2 &
• David G. Marrero 3  

Journal of Foot and Ankle Research volume  15 , Article number:  56 ( 2022 ) Cite this article

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Introduction

The mechanisms for the observed disparities in diabetes-related amputation are poorly understood and could be related to access for diabetic foot ulceration (DFU) care. This qualitative study aimed to understand patients’ personal experiences navigating the healthcare system and the barriers they faced.

Fifteen semi-structured interviews were conducted over the phone between June 2020 to February 2021. Participants with DFUs were recruited from a tertiary referral center in Southern Arizona. The interviews were audio-recorded and analyzed according to the NIMHD Research Framework, focusing on the health care system domain.

Among the 15 participants included in the study, the mean age was 52.4 years (66.7% male), 66.7% was from minority racial groups, and 73.3% was Medicaid or Indian Health Service beneficiaries. Participants frequently reported barriers at various levels of the healthcare system.

On the individual level, themes that arose included health literacy and inadequate insurance coverage resulting in financial strain. On the interpersonal level, participants complained of fragmented relationships with providers and experienced challenges in making follow-up appointments. On the community level, participants reported struggles with medical equipment.

On the societal level, participants also noted insufficient preventative foot care and education before DFU onset, and many respondents experienced initial misdiagnoses and delays in receiving care.

Conclusions

Patients with DFUs face significant barriers in accessing medical care at many levels in the healthcare system and beyond. These data highlight opportunities to address the effects of diabetic foot complications and the inequitable burden of inadequately managed diabetic foot care.

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Diabetic foot ulceration (DFU) is a common and often catastrophic complication for people with diabetes. In the United States, people with diabetes have an up to 34% lifetime risk of developing a foot ulcer [ 1 , 2 ], a medical complication that increases their five-year mortality rate by 2.5 times [ 3 , 4 ]. Moreover, foot ulceration is a causal factor for up to 85% of diabetic patients who subsequently undergo lower extremity amputation [ 1 , 5 ]. As compared to the overall United States population, people with diabetes are more likely to undergo lower extremity amputation and repeat amputations [ 1 , 6 ]. The annual medical cost associated with DFU care in the United States is an additional $9–13 billion on top of other costs associated with diabetes [ 7 ].

Moreover, DFUs and subsequent amputations are unevenly patterned along lines of racial and ethnic minority status, low socio-economic status, low insurance coverage rates, and geographic isolation. African American, Hispanic, and Native American adults with diabetes have higher prevalence of DFUs and amputation than their White counterparts [ 8 , 9 , 10 ]. Across the board, patients in the lowest income quartiles experience higher odds of amputation and death due to peripheral artery disease [ 11 , 12 ]. In addition, those with suboptimal or no medical insurance are at an elevated risk of major amputation [ 13 ]. This illuminates a glaring and yet unabated public health problem, especially among minority and low-income populations [ 8 , 9 , 12 , 13 , 14 , 15 , 16 ].

The mechanisms of these observed disparities in DFU incidence and progression are poorly understood [ 9 , 11 , 17 , 18 ]. There is evidence, however, indicating that access to affordable and quality medical care, preventive services, and limb salvage care is an important contributing factor to disparities in amputation rates [ 19 , 20 , 21 ]. This qualitative study aimed to understand patients’ personal experiences with DFUs in a safety net health system, including their processes of navigating the healthcare system and the barriers they faced. The themes elicited in the study concerning multiple barriers at varying levels of the healthcare system will help to improve health care delivery in a population experiencing elevated risks of diabetes-related ulceration and amputation.

This qualitative study was designed to better understand the various challenges faced by patients with a history of DFUs and lower extremity amputations as they managed their conditions and sought medical care. Semi-structured interviews were conducted between June 2020 to February 2021 and the results were analyzed according to the “Health Care System” domain of the National Institute on Minority Health and Health Disparities Research Framework [ 22 ]. The University of Arizona Institutional Review Board approved the study in July 2019 (Protocol Number 1906749805).

Participants

Patients were selected from the Southwestern Academic Limb Salvage Alliance (SALSA), a multidisciplinary limb salvage care team located in Tucson, Arizona, to participate in semi-structured interviews. SALSA treats over 5,000 patient visits annually for diabetic foot problems, of which 40% are from racial and ethnic minority groups. It is the primary referral center for limb salvage and care for minorities and patients with low socioeconomic status in suburban and rural Arizona. Participants were identified and approached for participation during scheduled clinic appointments or by follow-up phone calls by our research team. We purposely sampled participants, using criterion sampling, to reflect the diverse range of race/ethnicity, gender, history of DFU, foot infection, minor amputation (below the ankle), and major amputation (ankle or above) treated by SALSA [ 23 ].

Interview guide and data collection

The research team jointly developed a semi-structured interview guide to encourage patient perspectives regarding their living experiences with foot ulceration and how they sought care for DFUs. Interviews were conducted in the patients’ preferred language (English or Spanish). Three research team members experienced in qualitative interviews (R.M.C., K.N.B.P., and D.G.M.) completed 15 interviews over the phone, lasting 40–60 min each. Interviews were recorded with consent using the “Tape A Call” mobile application ( www.tapeacall.com ) or via the University of Arizona Health Sciences Zoom Platform. The interviews were conducted in phases to allow for simultaneous analysis and redirection of subsequent data collection.

The research team used the Dedoose software version 9.0.17 (SocioCultural Research Consultants, LLC, Los Angeles, CA) to assist in data storage, coding, and data analysis. Audio files of the interviews were transcribed into the language spoken. After a quality assurance check, the transcriptions were uploaded into the software. The transcripts were independently reviewed and coded by three members of the research team (R.M.C., K.N.B.P., and T-W.T.). Data for this article were analyzed according to the NIMHD Research Framework (2017) that includes a multilevel approach including individual, interpersonal, community, and societal-level factors. While this model includes several domains, for the purposes of this paper we are focusing only on the Health Care System domain. This framework has been used in health disparities research to conceptualize and evaluate a wide array of determinants that promote or worsen health disparities [ 24 ]. Team members met regularly to compare coding results and resolve discrepancies by discussion and consensus.

The study sample included 15 participants (Table 1 ). The mean age was 54.2 years. Eleven participants (73.3%) were Medicaid or Indian Health Program beneficiaries and 80% of participants were either unemployed or had retired. All participants had history of at least one DFU, 12 had a history of foot infection, eight underwent minor amputations, and one had a major amputation. Four patients underwent at least one open surgery or endovascular procedure due to peripheral artery disease. During the interviews, participants frequently reported barriers at various levels of the health care system (Table 2 , Fig.  1 ).

Patient reported barriers at all levels influence of the health care system domain

Individual Level of Influence

Health literacy.

While most participants were aware of the risks of foot infection and amputation, there were significant gaps in their health literacy that compromised their ability to make informed decisions about when and how to seek medical care. Most notably, although all participants had a history of DFUs, many were unfamiliar with the term “ulcer” and expressed confusion when interviewers asked questions using that term. This finding, which reflects poor communication by providers and medical staff, resulted in most participants using alternate terms such as “blister,” “callous,” “cut,” “infection,” and “injury” to describe their foot abnormalities. This confusion in terminology was critical, as many patients described not initially seeking medical care because they interpreted their foot abnormality to be a common, everyday problem rather than one warranting medical attention. As one participant described: “Nobody ever really said what I’m looking for just anything that is not normal, I guess. But like I said, I have never heard of a diabetic foot ulcer.” (57-year-old Hispanic male, history of DFU).

In addition, participants described gaps in their health literacy related to the specifics of foot ulcer progression and the appropriate management strategies to prevent amputation. Most participants did not have a solid understanding of warning signs for when medical care should be secured for foot problems or what type of medical care should be sought. One frustrated participant stated: “If I had gotten better, like a different type of information that they could’ve given me, that might’ve helped me improve this ulcer to be going away. From what I have been given, you know, it’s just hard. I don’t know if it’s my foot itself or if it’s the medication. I don’t know. I don’t know if I am a unique case, I know there are people out there that have one foot. And they are able to get, probably, their ulcer better” (29-year-old Native female, history of DFU and recurrent foot infection).

Insurance coverage

While all participants had medical care coverage under Medicaid, Medicare, Indian Health Services or commercial insurance, the majority described significant medical expenses and financial strain related to their diabetes care in general, and in many cases to DFU care in particular. Most of the participants reported multiple recurring expenses such as medications (particularly insulin), co-payments for specialist visits and procedures, and the need for extensive travel, a financial strain that was frequently exacerbated by temporary or permanent loss of employment and under-employment. One participant said that following his second toe amputation: “I was in the hospital for 15 days, 13 days. They are charging me a copay, but I don’t have money to pay it. I am currently not working. I have social security and they don’t give me very much and it’s not enough to cover the copay.” (67-year-old Hispanic male, commercial insurance). In addition, many described substantial out-of-pocket payments for ancillary supplies, such as diabetic footwear and wound dressings due to inadequate insurance coverage, which often resulted in participants being unable to secure the supplies and care they needed for optimal DFU management. For example, a participant explained: “They want me to get diabetic shoes and the orthotic but at the time I didn’t have Medicaid … and with the deductible, they wanted $1,000 for the pair of shoes and the orthotic and I couldn’t afford it.” (45-year-old White female, Medicaid).

Interpersonal Level of Influence

Patient–clinician relationships.

Participants reported a wide array of levels of satisfaction with their medical providers, from long-standing personal and medically supportive relationships to negative experiences of not being listened to or being bounced from provider to provider. A predominant theme involved fragmented relationships with healthcare providers due to multiple factors including patients’ changes in residence, transitions in insurance status, providers leaving the area or switching practices, providers’ medical and holiday leave, and the COVID-19 pandemic. Given the complexity of managing their diabetes and related complications, these interruptions to patient-clinician relationships posed considerable barriers to effective disease management.

In addition, participants mentioned challenges in making timely appointments, and in getting time with their primary care physicians after major clinical events such as hospitalizations. One patient explained: “I had a lot of problems getting in contact with that doctor (primary care doctor). And after, I think it was the first four months after the amputation, and I just kept on trying to contact her… and I would try to call her, and she never returned my calls.” (47-year-old Hispanic male, history of multiple DFUs, foot infection, and toe amputation).

Similar challenges existed around establishing trusting relationships with the nurses that conducted home wound care following DFUs and amputations. This was due in large part to turnover in nursing staff or the rotation of nurses who conducted their home visits. A participant explained: “They [the companies] make a big deal about bringing the nurse in and have them trained on me and then two weeks later, I get a new nurse and redo it.” (45-year-old White female, underwent more than 20 procedures for DFUs).

Lastly, participants reported that the COVID-19 pandemic further intensified this lack of provider continuity due to limited in-person visits. For example, one participant described his struggles to connect with a new endocrinologist during the pandemic, stating: “I see him once and a current situation came up, so I haven’t been able to see him since then. [Due to the pandemic] it has been phone interviews, so, I haven’t really developed any significant rapport with my current endocrinologist.” (41-year-old White male, history of recurrent DFUs and toe amputations).

Community Level of Influence

Availability of services.

Participants commonly reported struggles with getting the medical equipment needed to prevent and manage their DFUs in a timely fashion, including offloading braces, dressing supplies, and therapeutic shoes and insoles. A few noted that the wound supplies provided by the hospital, clinic, or home healthcare companies ran out before their wounds had healed. One participant described maintaining medical supplies as his biggest challenge, saying: “The nurses themselves have been wonderful but their companies have been mainly touch-and-go with maintaining the supplies being delivered at an appropriate time” (41-year-old White male, Medicaid). Despite having prescriptions from physicians and insurance coverage, many participants also faced long waits for securing specialized diabetic shoes from medical supply companies, resulting in delayed or interrupted care. One participant described: "The insoles that I went in for, that they prescribed for me, it took me a long time to get them. Probably like three months after … and then when I got them, they, they were very flimsy, they didn’t last. It took me awhile to get another pair, a better design of the ones that they had” (47-year-old Hispanic male, self-employed, commercial health insurance).

Participants living in rural areas outside of Tucson cited additional challenges in managing their DFUs due to the time, expense, and distance involved in securing the elaborate routines of specialist appointments, routines, medications, and wound care necessary to effectively manage their DFUs. One participant described: “It was a difficulty because I am on the reservation and sometimes the medical things that I would need, like I said, insulin, the IV antibiotics, they wouldn't be able to come out here and do it. If I had lived in a city, then the people would come and get it done.” (38-year-old Native male, Medicare, rural Arizona).

Societal Level of Influence

Quality of care.

Many participants noted insufficient preventative foot care and education prior to DFU onset. Some reported that they did not learn about ulcer prevention until they developed DFUs. For example, one participant stated: “I don’t really remember (doctors) saying anything on ways to prevent other ulcers.” (38-year-old Native male, Medicaid and Indian Health Services). Some participants similarly reported that they did not receive routine foot examinations prior to developing their first DFU, even though they had regularly scheduled primary care appointments. One explained: “Well, early on they didn’t look at my feet. Before I got the ulcer, they didn’t look at them. They would just instruct me to check my blood sugar. But then after the ulcer and when they cut off my toe, that’s when they started to check my feet.” (67-year-old Hispanic male, commercial insurance).

Other barriers presented themselves while seeking adequate medical care for their new ulcers. Participants initially sought care from a variety of different venues— primary care doctors, podiatrists, specialists, emergency rooms, and urgent care clinics— as determined by how serious they interpreted their foot problems and insurance status and access issues. Some participants had the experience of being sent to multiple facilities in search of appropriate care, and those living in rural areas faced travel to different cities or towns. For example, a participant recalled that: “I went to the ER down here in XXX (a community hospital) and that was Friday (was discharged home) and then I saw my doctor on Monday and he sent me to XXX (a tertiary hospital) in Tucson.” (41-year-old White male, history of multiple DFUs and two toe amputations).

Many respondents experienced initial misdiagnoses and delays in receiving care. This included a few participants who presented for diabetic foot complications to acute care facilities, such as urgent care clincs and emergency rooms, and were sent home without an appropriate diagnosis, treatment, and follow-up. One woman recalled her frustrating journey that led to amputation:

‘I called my doctor…. She told me I want you to see an infectious disease doctor and have them put you on an IV antibiotic …. So, I get to the infectious disease doctor, and he says, ‘I’m not going to put you on antibiotic, it isn’t infected.’ So, that’s how I ended up with an amputation because he did not put me on any antibiotic. So, I went into the hospital, and they assigned me an infectious disease doctor and she came in, I’ll never forget this, and she started talking to me like I was stupid, and she goes, ‘You know you’re diabetic, you should’ve gone to a doctor right away ...’ And I said, ‘… hold on a second here, I am a very intelligent person and yes, I did, I went to my own doctor who made an appointment for me to see an infectious disease doctor.” (71-year-old White female, history of multiple DFUs and toe amputations)

Over the past two decades, substantial advances in diabetes therapy have greatly extended health and reduced morbidity. However, as evidenced in this article, significant obstacles to effective DFU treatment and management remain at multiple levels of the healthcare system. Some of these obstacles can be mitigated with more thoughtful education and alignment of access points to receive adequate health care. In this context we offer observations from our study to help address these deficits, particularly as they relate to decreasing notable health disparities.

An important individual level barrier is deficits in health literacy surrounding appropriate terminology to describe diabetic foot complications and how to make informed medical decisions about when to seek medical intervention [ 25 ]. Our findings suggest that a more aggressive and tailored education approach that guides patients to act quickly in seeking medical care and for rapid wound examination is warranted. Part of this education needs to emphasize that diabetes increases the infection and amputation risks of these seemingly “minor” foot injuries. Burdensome expenses related to DFU care posed a second individual level barrier, suggesting the need for continued advocacy for full coverage of DFU care among safety net insurance providers [ 26 , 27 ].

On the interpersonal level, our data illustrate that disruptions to the patient-clinician relationship damages rapport with patients and hinders optimal DFU care. Study participants frequently reported difficulties in accessing appropriate health care providers and disruptions to the patient-physician relationship due to the turnover of providers, changes to region and insurance status, and other factors. This gap calls for developing solutions to address medical provider shortages and to “fill in” health care assessment in a timely manner. One potential approach is to expand the use of trained community health workers who can help triage persons with differing levels of foot ulcers to available health care providers who work outside of the patient’s known environment [ 28 , 29 ].

On the community level, despite having appropriate prescriptions and insurance coverage, participants described significant challenges receiving medical equipment, which was often perceived to be due to shortcomings at the medical supply companies. Since most persons with diabetes see their pharmacist more frequently than any other member of their health care team, developing collaborations between pharmacies, providers, or healthcare system in which pharmacists take on the role of providing medical equipment such as wound care supplies or diabetic shoes, may be an effective approach. Pharmacist supported diabetes care has been shown to be well received by minority patients and to result in improved diabetes outcomes [ 30 , 31 ].

Finally, on the societal level, there is a need to improve preventive care for DFUs on the primary care physician level, a crucial strategy for limb salvage. The American Diabetes Association recommends that all patients with diabetes have their feet inspected at each doctor visit and have a comprehensive foot evaluation at least annually to identify risk factors for DFUs [ 32 ]. Greater focus needs to be placed on educating medical providers and patients, and on the importance of preventive foot care including self-foot inspection, foot examination by a medical professional, and the use of appropriate footwear. In addition, given that sample participants commonly reported receiving misdiagnoses and delays after seeking medical care for DFUs, a standardized protocol and care pathway for when, where, and how patients should seek initial DFU care and how the DFUs should be treated are imperative. Because delays occur both before and after seeking care, a focus must be made to educate both patients and providers about the standard protocol [ 33 ].

There are limitations to this study which should be considered when interpreting the results. Given the relatively modest sample size, we were not able to analyze the data for gender or age effects or by duration of diabetes. Nonetheless, this hard to reach patient sample representing a diverse population did offer very similar stories about the experiences and health disparities they faced in dealing with DFUs.

Diabetic foot ulceration remains a common and life-altering disease complication and one that disproportionately burdens people of racial and ethnic minority status, low socio-economic status, low insurance coverage, and those residing in rural areas. Our study examined the lived experience of a sample of persons with diabetes that face significant barriers at all levels of the healthcare system. Their stories highlight the importance of selecting multiple points of entry to make significant improvements in peoples’ health literacy, relationships with providers, and access to quality and effective medical care, services, and medical supplies. Moreover, this approach should creatively incorporate multiple possible modes of service delivery, including the integration of community health workers and pharmacists. While there are considerable challenges to achieving this goal, concerted efforts are needed to reduce DFUs’ devastating effects on mortality and morbidity and the inequitable burden of poorly managed diabetes foot care among highly affected populations.

Availability of data and materials

The de-identified qualitative data that support the findings of this study are available from corresponding author upon reasonable request.

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Acknowledgements

Our team acknowledge the participants of the study.

The project is supported by a National Institute of Diabetes and Kidney Disease K23 Mentored Patient-Oriented Research Career Development Award (1K23DK122126) and a Society of Vascular Surgery Foundation Mentored Research Career Development Award Program (T-W.T) and a National Institute of Diabetes and Kidney Disease R01 (1R01124789) Award (D.G.A).

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Center for Health Disparities Research (CHDR), University of Arizona Health Sciences, Tucson, AZ, USA

Rebecca M. Crocker, Kelly N. B. Palmer & David G. Marrero

University of Arizona College of Medicine, Tucson, AZ, USA

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Contributions

Tze-Woei Tan: Conceptualization, Methology, Validation, Formal Analysis, Writing – Original Draft, Writing – Review & Editing, Supervision, Project Administration, Funding Acquisition. Rebecca M. Crocker: Conceptualization, Methology, Validation, Formal Analysis, Writing – Original Draft, Writing – Review & Editing. Kelly N.B. Palmer: Conceptualization, Methology, Validation, Formal Analysis, Writing – Review & Editing. Chris Gomez: Methology, Validation, Formal Analysis, Writing – Original Draft, Writing – Review & Editing. David G. Armstrong: Conceptualization, Methology, Writing – Review & Editing. David G. Marrero: Conceptualization, Methology, Validation, Formal Analysis, Writing – Original Draft, Writing – Review & Editing. The author(s) read and approved the final manuscript.

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Correspondence to Tze-Woei Tan .

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Tan, TW., Crocker, R.M., Palmer, K.N.B. et al. A qualitative study of barriers to care-seeking for diabetic foot ulceration across multiple levels of the healthcare system. J Foot Ankle Res 15 , 56 (2022). https://doi.org/10.1186/s13047-022-00561-4

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DOI : https://doi.org/10.1186/s13047-022-00561-4

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Enhanced population longevity, decrease in physical activity and the obesity pandemic have resulted in an increase in incidence of type 2 diabetes in all WHO health care areas. The prevalence of the condition has been further increased by an increase in life expectancy of those living with both type 1 and ...

Keywords : Diabetic Foot, Diabetic Foot Ulcers, Diabetic Foot Infections, Diabetic Foot Osteomyelitis, Lower limb amputation, Peripheral arterial disease, Diabetes peripheral neuropathy, Charcot Foot, Diabetic Foot Prevention, Therapeutic Shoes, Wound healing

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Improving the Management and Treatment of Diabetic Foot Infection: Challenges and Research Opportunities

Kaja turzańska.

1 Department of Clinical Microbiology, Royal College of Surgeons in Ireland University of Medicine and Health Sciences, Education and Research Centre, Beaumont Hospital, D09 YD60 Dublin, Ireland

Oluwafolajimi Adesanya

2 School of Molecular and Cellular Biology, University of Illinois Urbana-Champaign, Champaign, IL 61801, USA

Ashwene Rajagopal

Mary t. pryce.

3 School of Chemical Sciences, Dublin City University, D09 V209 Dublin, Ireland

Deirdre Fitzgerald Hughes

Associated data.

Not applicable.

Diabetic foot infection (DFI) management requires complex multidisciplinary care pathways with off-loading, debridement and targeted antibiotic treatment central to positive clinical outcomes. Local administration of topical treatments and advanced wound dressings are often used for more superficial infections, and in combination with systemic antibiotics for more advanced infections. In practice, the choice of such topical approaches, whether alone or as adjuncts, is rarely evidence-based, and there does not appear to be a single market leader. There are several reasons for this, including a lack of clear evidence-based guidelines on their efficacy and a paucity of robust clinical trials. Nonetheless, with a growing number of people living with diabetes, preventing the progression of chronic foot infections to amputation is critical. Topical agents may increasingly play a role, especially as they have potential to limit the use of systemic antibiotics in an environment of increasing antibiotic resistance. While a number of advanced dressings are currently marketed for DFI, here we review the literature describing promising future-focused approaches for topical treatment of DFI that may overcome some of the current hurdles. Specifically, we focus on antibiotic-impregnated biomaterials, novel antimicrobial peptides and photodynamic therapy.

1. Introduction

The International Diabetes Federation estimates that 537 million people were living with diabetes in 2021, representing 10% of the global population, which has increased by 1.2% in the past five years. It is predicted that this number will rise to 783 million by 2045 [ 1 ]. The development of diabetic foot ulcers (DFUs) is a complication of diabetes that is estimated to affect 9.1–26.1 million people annually with a global prevalence of 6.3% [ 2 ]. One Malaysian study reported an infection rate of DFUs of 41.5% [ 3 ], with a similar value of 40.1% being reported by an Australian study [ 4 ]. Wound infection in those with DFUs is among the strongest predictors of lower limb amputation [ 5 ], and more than one million diabetic patients suffer lower limb loss annually, as a result of failure of therapeutic interventions for treating diabetic foot infections [ 6 ]. Notably, the three-year mortality rate after the first amputation is between 20% and 50% [ 7 ]. In addition to obvious physical morbidity and mortality, DFUs also present significant psychological challenges for patients, including depression, emotional distress and anxiety disorders [ 8 , 9 , 10 ].

Diabetic foot infection (DFI) is the commonest cause of hospitalisation among those with diabetes [ 11 ] and the complexity of management may result in lengthened hospital stays and subsequently increased healthcare costs. Therefore, to ensure better clinical outcomes for patients, there is a critical need to effectively manage and treat these infections. In this review, we explore the unique challenges of resolving DFIs and outline the current clinical management approaches in relation to wound healing and antimicrobial therapy. We also describe alternative novel strategies that are currently under development and explore their potential to overcome the therapeutic challenges of DFI and improve outcomes for patients.

2. Host Factor and Infections of Diabetic Foot Ulcers

Diabetes-associated peripheral neuropathy impairs the distal nerves of the limbs, resulting in reduced pain sensations and progressive numbness. As a consequence, diabetic foot ulcers may develop and progress unrecognised following relatively minor external traumas. Irregular plantar pressure and shear stress on the foot associated with reduced foot mobility and abnormal structural features such as hammer toe and Charcot deformity may further facilitate ulcer progression [ 12 ]. Once a DFU becomes infected, the most important factor determining clinical outcome is peripheral arterial disease (PAD), a manifestation of atherosclerotic disease defined as the partial or complete obstruction of one or more arteries [ 13 ]. The rate of PAD is 2–4-fold higher in patients with diabetes [ 14 ]. PAD-associated vascular complications in diabetes contribute to perfusion deficits that reduce blood flow to infected tissue, resulting in significantly poor resolution of infected ulcers by limiting the supply of immune cells and mediators to DFIs. In addition, the innate immune responses that normally protect from infection are compromised by acute hyperglycaemia in diabetes. Several defects in neutrophil function in diabetic animal models and human studies have been shown, including reduced respiratory burst [ 15 ], limited phagocytic activity [ 16 ] and downregulation of toll-like receptors for pathogen recognition [ 17 ].

3. Complications and Risks for Poor Clinical Outcomes

The symptoms of wound infection commonly include purulent exudate, odour, erythema, warmth, tenderness, oedema, pain, fever and elevated white cell count. However, these clinical signs of infection may not all be present in the immunocompromised patient, the patient with poor perfusion or the patient with a chronic wound. The latter three conditions are common among diabetic patients, making DFIs inherently complex to diagnose, categorise and manage—requiring a multidisciplinary care approach involving podiatrists, vascular surgeons, tissue viability experts and clinical microbiologists. Furthermore, multiple classification schemes for diabetic foot complications exist, of which infection is often a defined parameter in the broader classification of ulceration severity. However, because infection severity is a major contributor to poor clinical outcomes, the classification system recommended by the Infectious Diseases Society of America (IDSA) and the International Working Group of the Diabetic Foot (IWGDF) shows utility in a clinical setting as a predictor of lower limb amputation [ 18 , 19 ]. This system is a modification of the PEDIS classification system, which assesses five main wound parameters: perfusion (P), extent (E), depth (D), infection (I) and sensation (S) [ 20 , 21 ].

The emerging trend towards greater prominence of PAD among people with diabetes adds further complexity to the pathophysiology of foot wounds, meaning that such wound characteristics as contained within the PEDIS classification may all contribute to patient clinical outcomes and ought to be assessed while classifying DFIs. The Society for Vascular Surgery’s integrated system of classification of the lower extremity threatened limb is based on Wound, Ischaemia and Foot Infection (WIfI) to better predict amputation risk [ 22 ]. Recently updated guidelines continue to recommend these two classification systems to guide infection management and support clinical decision making [ 23 ].

4. Aetiology of Diabetic Foot Infections

In the clinical management of DFUs, it is important to differentiate between colonisation and infection. Colonisation is defined as the presence of multiplying bacteria without an overt host immune response and is a feature of chronic wounds, usually involving bacteria of the normal flora [ 24 ]. Approximately one-half of DFUs become infected [ 25 ]. Therefore, understanding the complexity and microevolution of microbial aetiology in the environment of the diabetic foot is important in infection diagnosis and management. The transition from colonisation to infection occurs when colonising microorganisms invade the deeper tissues and overwhelm the protective immune defences. In the setting of diabetes, dysfunctional neutrophils and morphological changes in macrophages secondary to hyperglycaemia contribute to infection risk. According to the most recent recommendation from the IDSA, the diagnosis of clinical infection (a pre-requisite for antibiotic therapy), as distinct from wound contamination or colonisation, requires the presence of at least two signs or symptoms of inflammation and/or the presence of purulent discharge [ 26 ].

Although the aetiology of DFUs and DFIs are complex and often polymicrobial, Gram-positive cocci, mainly Staphylococcus aureus , remain the most common bacterial pathogen isolated from DFIs, followed by aerobic Gram-negatives, mainly Pseudomonas aeruginosa [ 27 , 28 ]. Other isolated bacteria include Enterococcus Spp., Enterobacterales and Group B Streptococci . For lower extremity infections, bacterial burden of ≥10 4 colony-forming units (CFU) per gram is considered the critical load at which infection becomes inevitable [ 29 , 30 ]. More recently, for DFI, lower thresholds have been shown to be clinically significant for specific organisms such as toxin-producing β-haemolytic Streptocooci or P. aeruginosa [ 31 , 32 ]. Xu et al. showed a delay in wound healing of up to 44% in diabetic neuropathic ulcers for each log increase in microbial CFU, as well as an association between poor wound healing and a 10 4 CFU threshold [ 33 ]. Primary infection of DFUs and shorter-duration infections generally involve one type of organism, but long-standing chronic infections, which are common in diabetic patients, tend to be polymicrobial, including both aerobic and anaerobic bacteria species. In addition to the multi-species (and multi-genera) characteristics of more advanced DFIs, the continuum of infection progression inevitably involves the production of biofilm [ 34 ]. Biofilm production facilitates the microbial aggregation, bound by a polysaccharide-, protein- or nucleic acid-rich extracellular matrix. Bacteria in biofilms are protected from the host immune responses and the effects of antibiotics based on the biofilm’s physical characteristics, the slower metabolism of cells within the structure and complex cell-to-cell communication [ 35 , 36 ]. Hence, many DFIs prove recalcitrant to conventional antibiotic therapy.

Given the complexity of both host and pathogen factors that may contribute to poor clinical outcomes in DFI, a multidisciplinary approach is the cornerstone of management with early intervention key to reducing risk of severe infection and amputation. This approach can include, for example, foot care and regular foot inspection for ulcer prevention and off-loading devices for treatment of ulcers caused by biomechanical stress. Debridement, the removal of slough and necrotic tissue, can promote healing and limit infection severity [ 37 ]. The choice of antibiotics for DFI is also complex, and factors including severity, causative pathogen/s, antibiotic resistance, oral bioavailability and achievable bone concentration must be considered [ 38 ]. Risk-reducing management and treatment require considerable and regular patient engagement with a range of medical, surgical and other healthcare services. Some treatments, e.g., surgery and systemic antibiotics, require patients to be hospitalised. Increasing levels of antimicrobial resistance (AMR) among DFI pathogens can also result in treatment failures. Consideration of novel and alternative approaches that mitigate the risk of severe infection or that facilitate self-management where possible should be considered.

5. Topical Antimicrobials for Treating DFIs

The 2012 guidelines of the IDSA recommended debridement and systemic antibiotics as the standard treatment for clinically infected wounds [ 26 ]. Topical treatments are recommended as monotherapy for more superficial infections, or in combination with systemic antibiotics for more advanced infections [ 39 ]. However, based on the continued lack of published studies to support their efficacy for treating DFIs, in the 2019 update to the 2016 IWDGF Guidelines on Management and Treatment of Foot Infection in Persons with Diabetes [ 40 ], current topical agents are not recommended as adjuvants for DFI treatment [ 23 ]. In theory, topical antibiotics for DFI have the potential to deliver high antimicrobial concentrations at the site of infection, bypassing disease-associated vascular insufficiencies. Several systematic reviews have been undertaken in this area with variable conclusions regarding the efficacies of systemic vs. topical modalities [ 39 , 40 , 41 , 42 , 43 ]. A systematic review of antimicrobial agents for chronic wounds, including DFUs, concluded that few systemic agents improved outcomes, but faster healing rates were achieved with the use of several topical substances [ 41 ]. Notably, Peters et al. reported that a novel antimicrobial peptide, Pexiganan, in a cream formulation, was similar in effectiveness to a systemic antibiotic (ofloxacin) in the treatment of mildly infected diabetic foot [ 44 ]. Despite the current paucity of randomised controlled trials of topical agents for DFIs, they potentially offer many benefits in this context, including local delivery of high and sustainable antimicrobial drug concentrations, reduced systemic absorption and lowered risk of toxicities [ 45 ]. More convenient application in an out-patient setting may also contribute to greater adherence rates and better treatment outcomes [ 46 ]. Indeed, a large retrospective cohort study involving 1378 patients showed more than 200% improvement in healing at any time point in those receiving personalised topical treatment guided by molecular diagnosis compared to those receiving standard-of-care treatment [ 47 ].

6. Strategies under Investigation with Potential in DFI Management

6.1. antibiotic impregnated biomaterials.

Adjunctive antimicrobial wound dressings are available clinically for inclusion in the management of DFIs and other chronic wound infections, but the choice of dressing is often patient or clinician experience-driven rather than evidence-based. Most of these dressings incorporate either iodine, silver or chlorhexidine, but quality randomised controlled trials are lacking to establish a clear evidence base. The properties of the dressing materials also require critical consideration of the nature of the infected wound and may differ for sloughy compared to granulating wounds. Dressing materials in current use include tulle, alginate, polyurethane foams, hydrocolloids and hydrogels [ 46 , 47 , 48 ].

In advancing topical treatment with antimicrobials, e.g., silver sulfadiazine (SSD) or conventional antibiotics, such as tetracycline or gentamicin, a wide range of functionalised biomaterials have been developed as targeted delivery vehicles for localised antimicrobial activity. Many developed in the last decade have been designed with additional desirable features such as antioxidant, anti-infective, debridement, immunoregulatory, and angiogenic properties [ 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ]. The potential efficacy of topical antibiotics in the treatment of DFIs or chronic wound infections has been explored in preclinical and clinical studies, with a few already being used clinically for patient care. For example, the silver sulfadiazine (SSD)-loaded chitosan microspheres (CSM) developed by Seetharaman et al. [ 52 ] in 2011 use a water-in-oil emulsion technique to impregnate SSD-CSM particles with polyethylene glycol fibrin gels. These gels showed in vitro bacterial killing with minimum inhibitory concentration (MIC) of 125 μg mL −1 and 100 μg mL −1 against S. aureus and P. aeruginosa , respectively, and have been translated to clinical use with encouraging results [ 53 ]. More recently, Pérez-Díaz and colleagues showed that chitosan gel formulations loaded with silver sulfadiazine were effective antimicrobial agents against methicillin-resistant S. aureus (MRSA) and P. aeruginosa within formed biofilms obtained from patients with chronic wound infections [ 54 ].

Calcium sulphate balls are a class of biodegradable carriers explored as functional antibiotic-impregnated biomaterials for treating DFIs and chronic wound infections. They have an excellent elution profile and can be impregnated with a broad range of water-soluble antibiotics including aminoglycosides, vancomycin, fluoroquinolones and daptomycin [ 45 ]. In a case study, tobramycin-impregnated calcium sulphate pellets were inserted into the diabetic foot ulcer cavity and used in combination with oral antibiotics for the successful treatment of forefoot osteomyelitis in a patient with diabetes [ 55 ]. Both Karr [ 56 ] and Morley et al. [ 57 ] have reported similarly successful results with vancomycin-loaded calcium sulphate and hydroxyapatite beads in the treatment of diabetic forefoot osteomyelitis. A significant benefit in the topical administration of antibiotics was shown by Price et al., who compared the in vitro efficacy of oral antibiotics with that of gentamicin-loaded calcium sulphate beads against P. aeruginosa , S. aureus and a polymicrobial biofilm containing bacteria harvested from diabetic foot infections [ 58 ]. They showed a 5–9 log reduction in microbial burden with the topically administered gentamicin-loaded calcium sulphate compared to only 0–2 log reduction for systemic antibiotic administration [ 58 ]. Biodegradable materials such as calcium sulphate offer significant clinical advantages by eliminating the need for surgical removal. Superior elution profiles have also been reported compared with the earlier non-biodegradable polymethylmethacrylate (PMMA) beads, which had poor sustained antibiotic release after the first 48–72 h of application [ 59 , 60 ].

While local delivery of antibiotics using these functional biomaterials offers a promising alternative and/or adjunct to systemic antibiotics for treating DFIs, well-designed clinical studies would further establish their efficacy under varying clinical conditions. While less complex regulatory pathways may exist for antibiotics with well-known safety and efficacy profiles than for biomaterials based on entirely new agents, the rates of antibiotic resistance among bacteria that cause DFI are likely to increase, presenting a further consideration in the development of antibiotic-based topical solutions.

6.2. Antimicrobial Peptides and Peptide-Based Polymers

Antimicrobial peptides (AMPs) are endogenous molecules that function in the innate immune system of different organisms, where they serve as a natural first line of defence against infections caused by a broad range of microbes, including Gram-positive and Gram-negative bacteria, anaerobic organisms, viruses and fungi [ 61 ]. Most AMPs are cationic in nature, initiating electrostatic interactions with their negatively charged phospholipid in the cell envelope of their bacterial targets (cytoplasmic membrane and Gram-negative outer membrane) [ 62 ]. AMP-mediated disruptive effects on the cell membrane vary and include the formation of membrane-spanning pores, distorted membrane curvature, the formation of aggregates or membrane dispersal, all of which are well described elsewhere [ 63 ].

In addition to their antimicrobial properties, natural AMPs also play important roles in wound healing. The AMPs LL-37 and β-defensins have been studied for wound healing activity and their effects include stimulating cytokine/chemokine production, promoting keratinocyte migration, proliferation and angiogenesis [ 64 , 65 ]. Chitosan hydrogel encapsulation of LL-37 stimulated effective wound repair with improved biocompatibility in a mouse wound model [ 66 ]. Other naturally occurring peptides, particularly those from various frog species, including Temporin-A ( Rana temporaria ) and Citropin 1.1. ( Litoria citropa ), show potent antimicrobial activity in vitro against 30 S. aureus (range 1–4 and 1–8 mg/L) and 30 P. aeruginosa isolates (range 8–64 and 2–16 mg/L) recovered from wounds [ 67 ]. A small 11-amino-acid peptide, CW49, promoted healing of a full-thickness skin wound in diabetic animals by mediating the upregulation of angiogenesis [ 68 ]. Anti-biofilm properties are critical in managing DFI, and AMPs have shown promising results in this regard. Another derivative of the frog skin AMP, esculentin-1, Esc (1–21)-1c, showed biofilm eradication concentrations of 12.5 μM against P. aeruginosa strains, comparable to that of colistin in vitro [ 69 ].

Investigation of AMPs for wound applications remains focussed largely on pre-clinical studies, the exception of which is pexiganan, the magainin derivative which progressed as a 1% cream formulation into phase III clinical trials, although it failed to meet the primary clinical endpoint of superiority over placebo [ 70 , 71 ] and had no clear advantage over systemic antibiotics. It is likely that harnessing the anti-polymicrobial and wound-healing properties of AMPs for applications in wound management will require chemical modifications and/or the use of novel delivery systems to reduce cytotoxicity and increase stability or biocompatibility while improving AMP targeting and prolonging their activity at the wound site. Collagen functionalised with LL-37 or its derivatives maintained antimicrobial activity and low cytotoxicity in vitro [ 72 ]. Notably, in terms of targeted delivery, Casciaro et al. engineered a derivative of the frog skin AMP, esculentin-1, Esc (1–21), for topical applications in wound infection. When conjugated to gold nanoparticles using polyethylene glycol as a linker, AuNPs@Esc (1–21) demonstrated wound-healing in a keratinocyte model and up to a 15-fold increase in anti-biofilm activity against P. aeruginosa with low cytotoxicity [ 69 , 73 ]. The amino acid homopolymer, ε-poly-L-lysine (ε-PL), composed of L-lysine residues, has shown broad-spectrum antimicrobial activity with wide-ranging potential applications in health and medicine [ 74 ]. Its application for wound infection management has been explored by integrating εPL into nanofiber dressings. In this form, it accelerated wound healing of bacteria-infected burns compared to standard-of-care silver dressings, in addition to low propensity for antimicrobial resistance development and high biocompatibility for skin cells [ 75 ].

Some of the limitations of natural AMPs, such as high production costs, stability issues and biodegradability, have been addressed by developments in synthetic antimicrobial polymers and peptide analogues with structures inspired by AMPs. These comprise polymer backbones with key antimicrobial structural features such as cationic charge and hydrophobic groups. One promising group is structurally nanoengineered antimicrobial peptide-based polymers (SNAPPs). They are star-shaped polypeptide nanoparticles usually rich in positively charged amino acids such as lysine, valine or arginine residues with multimodal bactericidal mechanisms involving lipopolysaccharide (LPS) targeting and outer membrane destabilisation or fragmentation [ 76 ]. Similar to linear AMPs, this results in lethal disruption of membrane function, along with membrane depolarisation or hyperpolarisation, and oxidative stress through the production of reactive oxygen species (ROS), all of which ultimately result in microbial cell death [ 77 ] ( Figure 1 ). Shirbin and colleagues reported that architectural modifications influenced the antimicrobial activity of star-shaped SNAPPs [ 78 ]. Through random opening polymerisation (ROP), they designed SNAPPs of varying arm numbers, and reported that increasing either the arm length or arm number resulted in greater antimicrobial activity [ 78 ]. They attributed this result to increased local concentration of polypeptide arms, but also observed that SNAPP cytotoxicity increased with increasing arm length and arm number. Through therapeutic index calculations, they identified the S16 and S4 structural isoforms to be the best therapeutic agents with the lowest toxicities [ 78 ]. Recently, our group demonstrated, using poly-L-lysine (PLL)-based SNAPPs, no statistically significant difference in bactericidal or anti-biofilm activity against S. aureus and P. aeruginosa reference strains for linear Vs star arrangements. Furthermore, using the linear form, PLL160, we showed 3.04 ± 0.16 and 3.96 ± 0.83 log reduction in CFU/mL of S. aureus and P. aeruginosa recovered from diabetic foot infections [ 79 ]. Unlike most antimicrobial therapeutics which only show direct bacterial killing, several studies have also shown that SNAPPs also possess potent immunomodulatory properties, stimulating the body’s innate immune response by recruiting neutrophils and monocytes to neutralise bacterial toxins and promote effective wound healing and angiogenesis [ 80 , 81 ]. These features make SNAPPs attractive candidate molecules for development as therapeutics for DFUs complicated by chronic antibiotic resistant infection.

Design features and novel bacterial membrane-specific interactions of structurally nano-engineered antimicrobial polypeptide polymers (SNAPPs): ( a ) Example of a SNAPP co-polymer structure, comprising a multifunctional initiator core of poly(amidoamine) or PAMAM, with m number of lysine or valine N-carboxyanhydride (NCA) polymeric arms complexed to its amino (NH 2 ) terminus. m could be 16 or 32 ( b ) ‘ core-first approach ’ for SNAPP synthesis, involving synthesis of PAMAM core from monomeric amidoamine starting materials followed by the complexing of polymeric lysine or valine NCA arms. ( c ) ‘ Arm-first approach ’ for SNAPP synthesis, involving initial synthesis of the arms by ring-opening polymerisation of monomeric units of lysine or valine NCA. ( d ) Antimicrobial action of SNAPPs involves electrostatic interactions between their negatively charged arms and the positively charged bacterial cytoplasmic membrane, leading to membrane disruption, penetration, pore formation and cell lysis. Figure constructed using the web tool at www.biorender.com .

6.3. Synergistic Antimicrobial Activity of Antimicrobial Peptides and Polymers with Antibiotics

One application of AMPs and synthetic AMP-based polymers that may have benefits in DFI management is their use as adjuncts to antibiotic therapy for maximal therapeutic efficacy. Such synergistic approaches would be critical in preventing the emergence and spread of bacterial resistance mechanisms against either entity, while re-sensitising previously resistant bacteria to antibiotics agents in an evolutionary trade-off. Using a checkerboard assay, de Gier and colleagues mapped the synergistic action of BA250-C10, a synthetic lipidated antimicrobial peptide polymer with either colistin or tobramycin, and showed that the combination effectively inhibited the in vitro growth of P. aeruginosa strains obtained from patients with cystic fibrosis, to a much greater extent than either agent could achieve alone [ 82 ]. Similar results were obtained by Amani et al., who showed that the antimicrobial peptide CM11 could be used in synergy with antibiotics against a range of clinically relevant bacteria strains, including S. aureus, P. aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii [ 83 ]. C12(ω7)K-β12, another lipopeptide-like synthetic molecule, could be used to rapidly induce a transient state of membrane depolarisation, which disrupted the proton-motive force required by bacterial antibiotic efflux pump and re-sensitised these previously resistant bacteria strains to intracellularly acting antibiotics [ 84 ].

In summary, AMPs and AMP-based polymers are effective candidate antimicrobial molecules against clinically relevant antibiotic-resistant bacteria, which complicate most DFUs. Their multimodal mechanism of action may limit the emergence of sophisticated resistance mechanisms in bacteria compared to conventional antibiotics. In addition, they have potential to re-sensitise previously antibiotic-resistant bacterial strains by disrupting bacterial membrane potential. AMP or AMP-based polymer-mediated immunomodulatory properties can promote wound healing and angiogenesis, and their unique structural properties allow for the fine-tuning of their antimicrobial action, making them promising alternatives and/or adjuncts to currently available DFUs/DFIs treatment options.

6.4. Photodynamic Therapy

Photodynamic therapy (PDT) employs a light source to generate reactive oxygen species via an excited photosensitiser (PS). This approach has been applied successfully in multiple clinical contexts. Photofrin R , a porphyrin-based material, was the first FDA-approved PS for treating a number of cancers, including oesophageal and skin cancers [ 85 ]. PDT is also used in chronic recurrent sinusitis, periodontitis, and for a range of other ophthalmological and dermatological indications [ 86 , 87 ]. Many compounds have been approved clinically as effective photosensitisers. In oncology, these are mainly tetrapyrrole compounds such as porphyrins, chlorins, bacteriochlorins and phthalocyanines. Other PDT compounds include phenothiazinium salts, methylene blue and toluidine blue O, which have been used in clinical trials for cancer chemotherapy and have been reviewed elsewhere [ 88 ].

There is growing interest in the antimicrobial applications of PDT for the topical treatment of infected wounds [ 88 , 89 , 90 ]. Antimicrobial PDT involves administering a non-toxic PS that is selectively accumulated by bacteria and not the surrounding tissue, followed by photo-activation with light of an appropriate wavelength to generate ROS such as free radicals and singlet oxygen, which are cytotoxic to bacterial cells [ 91 ]. Generation of ROS fromPSs is an oxygen-dependent process that takes place via a type I or type II reaction pathway. In the type I pathway, photo-induced interactions between the PS and biological substrates, such as amino acids and nucleic acids, produce superoxides by hydrogen or electron transfer. The resulting oxidative stress, particularly to lipid-rich bacterial cell membranes, causes irreversible damage and kills the bacteria cell. The type II pathway generates predominantly singlet oxygen by triplet energy transfer reactions between the PS and molecular oxygen [ 92 ]. As PSs can potentially bind to many sites in the bacteria cell, the lethal oxidative damage caused by PDT is non-specific. This is important for activity against AMR pathogens and greatly reduces the likelihood of developing resistance, as confirmed by several laboratory experiments [ 93 , 94 , 95 ]. In addition, anionic or neutral PS also damage DNA strands, lowering thymidine incorporation during DNA synthesis [ 96 ].

The favourable results from the in vitro application of antimicrobial PDT are well described, but fewer data are available for its in vivo preclinical application in animal models or clinical studies. Tanaka et al. compared the in vitro bactericidal activity of a commercial PS, Photofrin1 TM , to its activity in a murine MRSA arthritis model. They found that in vivo, too low or too high light doses were ineffective, and they noted the destruction of neutrophils at higher light doses [ 97 ]. Further work from these authors showed that the effects on murine neutrophils at higher light doses was PDT-type dependent with the more hydrophilic PDTs, e.g., toluene blue- or methylene blue-based PDTs, having the least toxicity to neutrophils [ 97 ]. Work by Zolfaghari et al. using a mouse wound model demonstrated <2 log reduction in CFU/mL of S. aureus in wounds following application of methylene blue-based PDT [ 98 ], whereas others have reported much higher efficacy levels of up to 5 log reduction using the same PDT in vitro, under comparable conditions of activation [ 99 ]. Similar differences in in vivo and in vitro antimicrobial efficacies have been reported for other PDTs [ 100 ]. Some examples of novelPSs that have shown relatively high in vitro activity that translated to promising in vivo activity in wound models of infection are summarised in Table 1 .

A phenothiazinium derivative, PPA904 [3,7-bis(N,N-dibutylamino) phenothiazin-5-ium bromide], progressed to a phase IIb controlled trial for applications in the care of infected wounds, including DFI. While only a small study of eight patients, a statistically significant reduction in bacterial load (approximately 1 log immediately after PDT treatment) and a trend towards wound healing were observed. The authors reported that the treatment was well-tolerated with an obvious improvement in wound healing within the treatment group compared to the placebo group [ 94 , 101 ]. Importantly, the authors noted the convenience and ease of use of PDT in the clinical environment, as reported by the healthcare workers involved in the trial. One Brazilian trial on a small number of patients ( n = 18) showed a reduction in the frequency of amputations in patients treated with PDT using phenothiazinium salts compared to the control group, reflecting increased rates of healing of the DFUs [ 102 ].

Another group of molecules that offer exciting prospects for the application of antimicrobial PDT for wound applications are those with the 4,4-difluoro-4-bora-3a,4a-diaza-s-indance structure, commonly referred to as BODIPYs. They possess desirable photophysical properties including large molar extinction coefficients in the visible light region, long emission wavelength and photostability. In addition, their chemical versatility facilitates the structural modification of these molecules to increase their production of singlet oxygen species. This is achieved by introducing heavy atoms such as iodine or bromine into their structure to create a high-efficiency triplet excited state, which ensures the efficient production of singlet oxygen [ 103 ]. This approach is, however, associated with its own challenges, including the reliance on halogens for antimicrobial activity and dark activity [ 104 ]. Li et al., recently reported the designs of a multifunctional BODIPYPS containing a positively charged guanidine group, LIBDP, with bactericidal properties that caused membrane destruction and inhibition of microbial proliferation of Gram-positive bacteria [ 105 ]. This PS generates reactive oxygen species upon light activation that destroyed pre-formed biofilms and oxidised nitric oxide in wounds to promote wound healing [ 105 ].

Lin et al. investigated structure–activity relationships of BODIPYs containing meso -Pyridinyl and methyl pyridinium or meso -pyridinium BODIPYs carrying hydrophobic head groups against S. aureus , Escherichia coli , Candida albicans and MRSA. Methyl-meso-(meta-pyridinium) BODIPY showed the highest phototoxicity against these pathogens with MICs ranging from 0.63 to 1.25 μM at a light dose of 81 J/cm 2 . This BODIPY group showed 3.59 to 7.05 log reduction in CFU/mL of S. aureus , including MRSA at concentrations from 0.31 to 5 µM, and 2.53 to 6.62 log reduction in CFU/mL of E. coli at concentrations from 1.25 μM to 5 μM. An in vivo aPDT study performed in a mouse S. aureus wound model using the methyl-meso-(meta-pyridinium) BODIPY formulated into a hydrogel to treat the infected area showed visible wound healing and significant reduction in bacterial load within 8 days.

Reducing the bacterial burden of chronic ulcers helps to reduce the risk of infection but also removes a potential barrier to effective wound healing. Conventional antibiotics have limited efficacy due to poor tissue penetration, increasing bacterial resistance and the risk of allergic contact reactions with topical antibiotics. In contrast, aPDT can promote healing by modulating growth factors production even in the absence of any antimicrobial activity. Statius van Eps et al. showed that PDT in a vascular smooth muscle cell injury model, stimulated endothelial cell growth by inactivating transforming growth factor-beta (TGF-β). However, the authors cautioned that further work is required to establish optimal dosing, noting inhibition of mediators of wound healing with sub-therapeutic PDT [ 106 ]. More recently, Mills and colleagues showed that topical application of methyl aminolevulinic acid (MAL)-photodynamic therapy specifically increased TGF-β3 and metalloproteinase 1 and 9 production to stimulate matrix remodelling and the production of scars with improved dermal matrix architecture following excision skin wounding [ 107 ].

Examples of novel photosensitisers with antimicrobial PDT activity in vitro and in vivo.

a A summary of the main activities is given, along with the microorganisms investigated, their level of killing (log reduction in colony-forming units (CFU)/mL) and the concentration of compound tested. For in vivo testing, summary is of the animal model, bacteria investigated and main findings. b The wavelength of light used for compound activation. c Reported quantum yield of singlet oxygen, where quantum yield is the number of molecules undergoing a photochemical event per absorbed photon.

6.5. Combination of PDT with Antibiotics

Interestingly, a synergy between PDT and penicillin antibiotics has been demonstrated in some studies, suggesting its potential as an adjunct to antibiotics. Iluz et al., using a checkerboard method, demonstrated synergistic antimicrobial activity against S. aureus using deuteroporphyrin (DP)-PDT with oxacillin but not with vancomycin, gentamicin, fusidic acid or rifampicin [ 113 ]. Additionally, they reported that while DP-PDT alone resulted in a 3–6 log reduction in viability of cells within mature S. aureus biofilms, its efficacy further increased by 3 log reduction when combined with oxacillin. The authors speculated that the impaired penicillin resistance among PDT survivors may reflect damage to plasmids that mediate beta-lactamase production based on earlier studies showing damage to supercoiled plasmid DNA in response to PDT [ 96 ].

Photodynamic therapy has the potential to either reduce infection burden or eradicate infection completely. Its multiple bacterial targets may both abrogate existing resistance of pathogens to conventional antibiotics while limiting the development of new resistance mechanisms. The flexibility of feasible structural modifications within PS structures are also attractive for the future development of technologies towards wound healing applications for DFUs and other infected wound types. With well-designed clinical and preclinical studies, photodynamic therapy could be progressed into clinical practice for the treatment of multi-drug resistant wound infections. Perhaps the most appealing aspect of antimicrobial PDT is its potential for use in outpatient clinics at relatively low costs. Hospitalisation may not be required when using PDT, which reduces the cost of treatment by several orders of magnitude. It is also associated with the use of already available light sources and inexpensive photosensitisers.

7. Conclusions

The management of infected DFUs is a critical component of the holistic management of the diabetic patient. Numerous approaches including antimicrobial peptides and peptide-based polymers, photodynamic therapy and antibiotics-impregnated biomaterials have been investigated in preclinical studies, with promising antimicrobial activity often against bacteria in biofilm growth modes. However, there is an urgent need to progress them into the clinic, through well-designed randomised controlled trials to generate much-needed evidence of clinical efficacy. These approaches present multimodal benefits of being applicable both as stand-alone therapies and as adjuncts to long-standing antibiotics, which have become less potent in the wake of rising antibiotic resistance. They also offer the advantage of being effective both as antimicrobial agents and promoters of wound healing—a benefit that cannot be overstated in the setting of diabetic foot infections.

Funding Statement

This work was funded by the Health Research Board of Ireland (HRB) and Diabetes Ireland Research Alliance (DIRA) (co-fund) through Health Research Charities Ireland (HRCI), grant number HRBMRCG-2018-01 (A.R.), and Science Foundation Ireland, Frontiers for The Future Programme, grant number 19/FFP/6882 (K.T.).

Author Contributions

Writing—original draft preparation, K.T., O.A., A.R., D.F.H.; writing—review and editing, D.F.H., M.T.P.; funding acquisition, D.F.H., M.T.P. All authors have read and agreed to the published version of the manuscript.

Institutional Review Board Statement

Informed consent statement, data availability statement, conflicts of interest.

D.F.H. and M.T.P. received funding from Science Foundation Ireland and Health Research Board of Ireland and Diabetes Ireland Research Alliance to develop and investigate novel materials for antimicrobial photodynamic therapy. The funders had no role in the writing of the manuscript.

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Latest List of Best Diabetes Dissertation Topics

Published by Owen Ingram at January 2nd, 2023 , Revised On May 17, 2024

The prevalence of diabetes among the world’s population has been increasing steadily over the last few decades, thanks to the growing consumption of fast food and an increasingly comfortable lifestyle. With the field of diabetes evolving rapidly, it is essential to base your dissertation on a trending diabetes dissertation topic that fills a gap in research. 

Finding a perfect research topic is one of the most challenging aspects of dissertation writing in any discipline . Several resources are available to students on the internet to help them conduct research and brainstorm to develop their topic selection, but this can take a significant amount of time. So, we decided to provide a list of well-researched, unique and intriguing diabetes research topics and ideas to help you get started. 

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List of Diabetes Dissertation Topics

• Why do people recently diagnosed with diabetes have such difficulty accepting reality and controlling their health?
• What are the reactions of children who have recently been diagnosed with diabetes? What can be done to improve their grasp of how to treat the disease?
• In long-term research, people getting intensive therapy for the condition had a worse quality of life. What role should health professionals have in mitigating this effect?
• Why do so many individuals experience severe depression the months after their diagnosis despite displaying no other signs of deteriorating health?
• Discuss some of the advantages of a low-carbohydrate, high-fat diet for people with diabetes
• Discuss the notion of diabetes in paediatrics and why it is necessary to do this research regularly.
• Explain the current threat and difficulty of childhood obesity and diabetes, stressing some areas where parents are failing in their position as guardians to avoid the situation
• Explain some of the difficulties that persons with diabetes have, particularly when obtaining the necessary information and medical treatment
• Explain some of the most frequent problems that people with diabetes face, as well as how they affect the prevalence of the disease. Put out steps that can be implemented to help the problem.
• Discuss the diabetes problem among Asian American teens
• Even though it is a worldwide disease, particular ethnic groups are more likely to be diagnosed as a function of nutrition and culture. What can be done to improve their health literacy?
• Explain how self-management may be beneficial in coping with diabetes, particularly for people unable to get prompt treatment for their illness
• Discuss the possibility of better management for those with diabetes who are hospitalised
• What current therapies have had the most influence on reducing the number of short-term problems in patients’ bodies?
• How have various types of steroids altered the way the body responds in people with hypoglycemia more frequently than usual?
• What effects do type 1, and type 2 diabetes have on the kidneys? How do the most widely used monitoring approaches influence this?
• Is it true that people from specific ethnic groups are more likely to acquire heart disease or eye illness due to their diabetes diagnosis?
• How has the new a1c test helped to reduce the detrimental consequences of diabetes on the body by detecting the condition early?
• Explain the difficulty of uncontrolled diabetes and how it can eventually harm the kidneys and the heart
• Discuss how the diabetic genetic strain may be handed down from generation to generation
• What difficulties do diabetic people have while attempting to check their glucose levels and keep a balanced food plan?
• How have some individuals with type 1 or type 2 diabetes managed to live better lives than others with the disease?
• Is it true that eating too much sugar causes diabetes, cavities, acne, hyperactivity, and weight gain?
• What effect does insulin treatment have on type 2 diabetes?
• How does diabetes contribute to depression?
• What impact does snap participation have on diabetes rates?
• Why has the number of persons who perform blood glucose self-tests decreased? Could other variables, such as social or environmental, have contributed to this decrease?
• Why do patients in the United States struggle to obtain the treatment they require to monitor and maintain appropriate glucose levels? Is this due to increased healthcare costs?
• Nutrition is critical to a healthy lifestyle, yet many diabetic patients are unaware of what they should consume. Discuss
• Why have injuries and diabetes been designated as national health priorities?
• What factors contribute to the growing prevalence of type II diabetes in adolescents?
• Does socioeconomic status influence the prevalence of diabetes?
• Alzheimer’s disease and type 2 diabetes: a critical assessment of the shared pathological traits
• What are the effects and consequences of diabetes on peripheral blood vessels?
• What is the link between genetic predisposition, obesity, and type 2 diabetes development?
• Diabetes modifies the activation and repression of pro- and anti-inflammatory signalling pathways in the vascular system.
• Understanding autoimmune diabetes through the tri-molecular complex prism
• Does economic status influence the regional variation of diabetes caused by malnutrition?
• What evidence is there for using traditional Chinese medicine and natural products to treat depression in people who also have diabetes?
• Why was the qualitative method used to evaluate diabetes programs?
• Investigate the most common symptoms of undiagnosed diabetes
• How can artificial intelligence help diabetes patients?
• What effect does the palaeolithic diet have on type 2 diabetes?
• What are the most common causes of diabetes and what are the treatments?
• What causes diabetes mellitus, and how does it affect the United Kingdom?
• The impact of sociodemographic factors on the development of type II diabetes
• An examination of the link between gut microbiome and diabetes risk
• The effectiveness of lifestyle interventions in preventing type II diabetes
• The role of maternal diabetes in offspring’s risk of developing diabetes
• Artificial intelligence in diabetes diagnosis and management
• Continuous glucose monitoring
• Telehealth interventions for improving diabetes self-management
• The role of wearable technology in diabetes management
• Personalised medicine approaches for diabetes treatment
• The impact of diabetes on mental health and well-being
• The link between diabetes and cognitive decline
• The potential of stem cell therapy for diabetes treatment
• Advances in closed-loop insulin delivery systems
• The use of glucagon-like peptide-1 (GLP-1) receptor agonists in diabetes treatment
• Investigating the efficacy of new oral medications for type II diabetes
• The role of bariatric surgery in the management of type II diabetes
• Improving patient adherence to diabetes treatment regimens
• The role of social support in diabetes management
• Developing culturally sensitive diabetes education programs
• The role of dietary patterns in diabetes prevention and management
• Low-carbohydrate vs. Mediterranean diet for diabetes: A comparative study
• The use of artificial sweeteners in diabetes management: Benefits and risks
• The impact of the gut microbiome on dietary interventions for diabetes
• The role of exercise in improving glycemic control
• Developing effective exercise programs for individuals with diabetes
• The impact of physical activity on diabetic complications
• Promoting physical activity adherence in people with diabetes
• The use of exercise gamification to increase physical activity in diabetes
• The potential of CRISPR gene editing for diabetes treatment
• The role of the microbiome in the development and treatment of diabetes
• An analysis of the artificial Pancreas systems
• The use of big data analytics in diabetes research
• The impact of environmental factors on diabetes risk
• Cost-effectiveness of different diabetes treatment strategies
• Developing effective diabetes prevention programs for communities
• The role of government policies in addressing the diabetes epidemic
• Improving access to diabetes care in underserved populations
• The impact of social determinants of health on diabetes risk
• Management of diabetes in children and adolescents
• The unique challenges of diabetes management in older adults
• Diabetes in ethnic minorities: Disparities in prevalence and care
• The impact of diabetes on LGBTQ+ populations

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You can contact our 24/7 customer service for a bespoke list of customised diabetes dissertation topics , proposals, or essays written by our experienced writers . Each of our professionals is accredited and well-trained to provide excellent content on a wide range of topics. Getting a good grade on your dissertation course is our priority, and we make sure that happens. Find out more here . 

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How to find diabetes dissertation topics.

To find diabetes dissertation topics:

• Study recent research in diabetes.
• Focus on emerging trends.
• Explore prevention, treatment, tech, etc.
• Consider cultural or demographic aspects.
• Consult experts or professors.
• Select a niche that resonates with you.

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• Risk Factors
• Providing Care
• Living with Diabetes
• Clinical Guidance
• DSMES for Health Care Providers
• Prevent Type 2 Diabetes: Talking to Your Patients About Lifestyle Change
• Employers and Insurers
• Community-based Organizations (CBOs)
• Toolkits for Diabetes Educators and Community Health Workers
• National Diabetes Statistics Report
• Reports and Publications
• Current Research Projects
• National Diabetes Prevention Program
• State, Local, and National Partner Diabetes Programs for Public Health
• Diabetes Self-Management Education and Support (DSMES) Toolkit

Preventing Diabetes-Related Amputations

What to know.

• Lower-limb amputations (LLA), which is surgery to remove a toe, foot, or leg, are increasing in the United States.
• 80% of LLAs are a result of complications from diabetes.
• Find out signs, symptoms, and steps to prevent diabetes-related amputations.

How diabetes can lead to an LLA

High blood sugar over time can cause diabetes complications that raise the chance of an LLA:

Peripheral arterial disease can narrow the blood vessels that carry blood to your legs and feet. Poor blood supply can make even a tiny cut heal slowly or not at all.

Peripheral nerve damage can cause loss of sensation so you may not notice cuts, sores, or ulcers on your feet.

With these complications, even a small cut can become a serious infection. Depending on the condition, a doctor may recommend one or more of these treatments:

• Procedure to clean the wound and remove dead tissue.
• Surgery to restore blood flow to your leg or foot (called revascularization).
• Antibiotics to treat certain infections.
• Amputation to remove the affected area.

How to prevent an LLA

You can reduce your risk for an LLA by managing your blood sugar through healthy eating and being physically active. You can prevent or delay foot problems through:

• Foot checks at home.
• Foot screenings at doctor visits.
• Wound care.

Diabetes self-management education and support (DSMES) is available if you need it. There you'll learn how to manage your blood sugar, cope with challenges, and prevent diabetes complications like LLAs.

When to see a doctor

Check your feet every day, so you can recognize any foot problems before you're at risk of an LLA. If you have any of the following symptoms, don't wait until it becomes a serious infection. See your primary doctor or foot doctor right away if:

• You have pain or numbness in your limb.
• You have a fungal infection such as athlete's foot between your toes.
• You notice a change in the color of your feet or swelling in your feet.
• The corner or side of your toenail grows into the soft flesh.
• A wound, sore, blister, or ulcer doesn't seem to be healing.
• You have an ulcer bigger than 3/4 inch deep and you can see the bone underneath.

What to do when you get a cut on your foot

Follow these steps to clean the wound:

• Wash your hands thoroughly with soap and clean water.
• Apply direct pressure to the wound with a clean bandage or cloth to control bleeding.
• Rinse the wound with bottled or clean running water. Wash around the wound with soap and clean water but don't get soap in the wound.
• Pat it dry with a clean towel. You may also want to apply an antibiotic ointment.
• Cover the cleaned wound with a new bandage and check it every 24 hours.

Seek medical attention if:

• The wound came from an animal bite or a puncture by a dirty object.
• There's dirt, glass, metal, or any other material in the wound that you can't remove on your own.
• Bleeding doesn't stop after applying pressure for 20 to 30 minutes.
• There are signs of infection like pain, redness, swelling, or fever.

What if you don't have a doctor?

There are free or low-cost options for preventing LLAs:

Medicare covers a foot exam once a year and some treatments for foot injuries or diseases.

Medicaid covers foot care in some states. Check with your state Medicaid agency to find out what foot care services are covered in your plan.

Federally qualified community health centers provide low-cost primary care services in both urban and rural areas.

How LLA rates vary by community

Some people with diabetes have a higher risk of LLA due to unequal opportunities to live a healthy lifestyle. This is known as a health inequity. Some people experience several health inequities, which can overlap.

Region: People with diabetes living in the Southern United States have the highest rate of LLAs. This may be because many people in rural areas in Southern states have limited access to health care and healthy foods. People who live in neighborhoods without safe spaces for physical activity may also have a higher risk of LLA.

Race and ethnicity: Among all racial and ethnic groups, Black adults with diabetes had the highest rate of LLAs in 2019. Black adults are 30% more likely to have an LLA compared with White adults with diabetes. They're 65% more likely than Hispanic or Latino adults with diabetes. Barriers to quality care and potential biases in the medical system may contribute to these higher rates.

Health literacy is the degree to which people can find, understand, and use information to inform health-related decisions. When health information is filled with unfamiliar terms, it creates barriers for people with limited health literacy. People with lower health literacy have higher rates of LLAs.

Social determinants of health (SDOH) also impact health outcomes and the risk of LLAs. SDOH are the conditions in which people are born, grow, work, live, and age. Low income, unstable work environments, and unreliable transportation can create barriers in accessing quality health care and preventing LLAs.

Diabetes is a chronic disease that affects how your body turns food into energy. About 1 in 10 Americans has diabetes.

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