Reviewing recommendations from the IWGDF 2023 guidelines on the diagnosis and treatment of active Charcot neuro-osteoarthropathy: highlighting the role of temperature monitoring with illustrative case reports.

The International Working Group on the Diabetic Foot (IWGDF) has consistently published evidence-based guideline recommendations on the prevention and management of diabetes-related foot complications. In 2023, the group published their first guidelines on the diagnosis and treatment of Charcot neuro-osteoarthropathy (CNO) in persons with diabetes. The guidelines highlight 26 recommendations based on 4 categories: diagnosis, identification of remission, treatment, and prevention of re-activation. As reviewed in the guidelines, there are 2 recommendations suggesting the use of temperature assessment and monitoring as a tool for management of patients with CNO. Utilizing the systematic review and the GRADE system of evaluation, the authors deemed the level of evidence around temperature monitoring and Charcot to be low with a conditional recommendation for use. The purpose of this manuscript is to summarize the IWGDF guidelines while highlighting the role of foot temperature monitoring. Several case examples are given to illustrate the use of temperature monitoring in patients with CNO. Until there are guidelines determining active vs quiescent CNO, skin temperature monitoring can be a fast, easy-to-use, and effective tool for the clinician.

Use of a novel human keratin matrix improves healing rates in diabetic lower extremity wounds.

BACKGROUND: Lower extremity wounds in patients with diabetes are difficult to heal due to an overabundance of pro-inflammatory M1 macrophages, reduced phagocytosis of necrosed cells, and circulatory issues. Keratin biomaterials have been shown to address some of these concerns by encouraging the proliferation of anti-inflammatory M2 macrophages, thereby creating more favorable conditions for wound healing resembling those of patients without diabetes. OBJECTIVE: To investigate the effect of a novel human keratin matrix (HKM) on wound healing. MATERIALS AND METHODS: Ten patients with diabetes with lower extremity wounds at risk for delayed healing underwent wound debridement and application of HKM. Patients received weekly follow-up care and reapplication of HKM until healing occurred; wound size at each visit was used to calculate healing rate. RESULTS: Increased healing rates were noted with HKM compared with standard of care (SOC), including debridement and collagen treatment in all 8 patients who had received SOC prior to HKM treatment. When HKM treatment was alternated with SOC in 2 patients due to other medical conditions, healing rates decreased with SOC and then increased after reintroduction of HKM applications. CONCLUSIONS: These results suggest that HKM may help regulate the pathological processes that contribute to wound chronicity to "kick-start" wound healing. This case series demonstrates that HKM is a promising technology to improve healing rates in nonhealing lower extremity wounds in patients with diabetes.

Examining characteristics of those who receive pedorthic services: A clinical audit.

Diabetes-related foot complications, including neuropathic plantar forefoot ulcers, are a significant contributor to morbidity and increased healthcare costs. This retrospective clinical audit examines the characteristics of people accessing pedorthics services who are at risk of neuropathic plantar forefoot ulcer (re)occurrence and the pathways and funding models used to access these services. A clinical record audit was conducted on all patients accessing a pedorthics service who had diabetes and neuropathy with a history of plantar forefoot ulceration. The data included demographics, diabetes and neuropathy duration, main forefoot pathology and other comorbidity, footwear and insole interventions, and health fund access status. A total of 70 patient records were accessed, and relevant data was extracted. The mean age of participants was 64.69 (standard deviation (SD) 11.78) years; 61% were male and 39% female. Duration of diabetes ranged from one to 35 years, with a mean of 14.09 years (SD 6.58). The mean duration of neuropathy was 8.56 (SD 4.16) years. The most common forefoot conditions were bony prominences at 71% (n = 50), rigid flat foot and limited joint mobility (53%, n = 37), and hallux abductovalgus at 47% (n = 33). All participants had hyperkeratosis; 34% (n = 24) had forefoot amputation, and around 34% (n = 24) had a history of digital amputation. Various publicly funded packages and private health insurance were accessed. This study investigates the sociodemographic and medical profiles of individuals with diabetes-related foot complexities prone to neuropathic plantar forefoot ulcers. It is the first to examine patients receiving pedorthic services, informing practitioner surveys and preventive care strategies. Understanding patient characteristics aids in optimising multidisciplinary care and reducing ulcer incidence. Further studies are warranted to explore the field to establish an effective multidisciplinary care approach between medical professionals, podiatrists and pedorthists to optimise patient outcomes.

Diabetic Foot Ulcers in Geriatric Patients.

Care for the patient with diabetic foot ulcers (DFUs) entails understanding the epidemiology, pathophysiology, and a systematic approach to diagnosis and treatment. The authors will review elements of DFU in geriatric patients including the pathophysiology of diabetes, epidemiology and management of DFU in the context of developing a Plan for Healing. The authors will discuss comprehensive principles of a Plan for Healing, which applies to all aspects of chronic wounds.

Effect of hyperbaric oxygen therapy on diabetes-related oral complications.

Background: Diabetes Mellitus is a chronic disease characterized by uncontrolled blood sugar levels, which lead to end-organ damage. While the diagnosis and treatment of its complications have been extensively studied, the effect of Hyperbaric Oxygen Therapy (HBO2) on diabetes-related oral complications remains unexplored. Aim: This prospective clinical study aims to investigate the effect of HBO2 on diabetes-related oral complications. Methods: Twenty patients diagnosed with diabetic foot ulcers and scheduled for HBO2 were included in this study. We recorded stimulated and unstimulated saliva pH, buffering capacity, flow rate, and subjective symptoms such as dry mouth, halitosis, taste loss, difficulty swallowing, and clinical examination findings before HBO2 and after the 21st session. Results: Upon comparing the findings, we observed a significant decrease in dry mouth and halitosis, periodontal disease severity, and healing of candida-related stomatitis and angular cheilitis. Despite not reaching statistical significance for other saliva parameters, the unstimulated salivary flow rate increased to normal limits (0.3-0.4 ml/min) in 6 out of 8 patients with a flow rate of less than 0.25 ml/min. Conclusion: Our study investigated the effect of HBO2 on diabetes-related oral complications for the first time, highlighting symptomatic relief for dry mouth and halitosis. Although our results are insufficient to report a definitive benefit, they underscore the need for further research on the oral health effects of HBO2.

The interplay between patients and healthcare professionals in a cross-sectoral setting in connection with the treatment and care of patients with diabetic foot ulcers: a realistic evaluation.

BACKGROUND: Diabetes-related lower extremity complications such as diabetic foot ulcer (DFU) are a global disability burden. Treatment and care for patients with DFU call for a multisectoral approach that incorporates interdisciplinary care pathways. We aimed to explore the interplay between patients with DFU and healthcare professionals in cross-sectoral settings that address treatment and care and to determine "what works, for whom, and under what circumstances". METHOD: The study was designed as a realistic evaluation. The data were generated from September 2022 to March 2023 and drew upon approximately 60 h of participant observation of 14 patients during the treatment and care of DFUs in their homes (primary care) and/or at outpatient clinics (wound specialist clinics in a hospital setting) in a Danish cross-sectoral setting. The Standards for Reporting Qualitative Research (SRQR) were applied in this study. RESULTS: We identified three illuminating themes that described the interplay between patients with DFU and related healthcare professionals representing both primary and secondary health care systems: (1) humour is a relationship-enhancing element between nurses and patients; (2) support from patients' coping strategies promotes patient-centeredness and collaboration; and (3) patients and professionals occupy unnegotiated identity roles. CONCLUSION: Our study led to a refined programme theory developed through the realistic evaluation process that allows us to propose an answer to the problem of "what works, for whom, and under what circumstances". The interplay between patients with DFU and healthcare professionals in a cross-sectoral setting for treatment and care is characterised by the use of humour as a relation-enhancing element and by improving support for patient coping strategies, which encourages healthcare professionals to promote health literacy. Future research should examine strategies for negotiating identity roles between patients with DFU and healthcare professionals to enhance collaboration, patient health literacy, and health promotion in cross-sectoral healthcare settings.

Diabetic foot self-care knowledge and practice among patients with diabetes attending diabetic clinic in the Gambia.

Diabetic foot ulcer is the most common complication causing lots of admissions among diabetic patients. Understanding patients' level of foot self-care knowledge, practice and associated factors is important for planning interventions to control and prevent diabetic foot complications. This study aimed to assess the level of knowledge and practice of foot self-care among diabetic patients attending diabetic clinics in The Gambia. Two hundred and seventeen patients attending diabetic clinics in two public hospitals were selected using a successive sampling technique. Data were collected using a validated interviewer-administered questionnaire. Descriptive statistics were used to summarize the demographic and clinical data. Multivariate logistic regression was used to identify factors associated with foot self-care knowledge and practice. The findings showed a poor level of foot self-care knowledge (n = 114; 52.5%) and practice (n = 149; 68.7%). Patients' educational level was statistically significantly association with diabetic foot self-care knowledge (p = 0.02). Diabetic foot ulcer history (aOR = 0.23, 95% CI: 0.08-0.63; p < 0.001), diabetic hospitalization (aOR = 2.41, 95% CI: 1.23-4.75, p = 0.01) and diabetic foot care education (aOR = 2.65, 95% CI: 1.39-5.06, p < 0.001) were statistically significantly associated with foot self-care practice. The poor diabetic foot self-care knowledge and practice among these patients emphasize the need for a diabetic health education program in these clinics.

Affordable web-based foot-ankle exercise program proves effective for diabetic foot care in a randomized controlled trial with economic evaluation.

The aim of this study was to shed light on a crucial issue through a comprehensive evaluation of the cost-effectiveness and cost-utility of a cutting-edge web-based foot-ankle therapeutic exercise program (SOPeD) designed for treating modifiable risk factors for ulcer prevention in individuals with diabetes-related peripheral neuropathy (DPN). In this randomized controlled trial, 62 participants diagnosed with DPN were assigned to the SOPeD software or received usual care for diabetic foot. Primary outcomes were DPN symptoms and severity, foot pain and function, and quality-adjusted life years (QALYs). Between-group comparisons provided 95% confidence intervals. The study also calculated incremental cost-effectiveness and cost-utility ratios (ICERs), analyzed direct costs from a healthcare perspective, and performed a sensitivity analysis to assess uncertainty. The web-based intervention effectively reduced foot pain, improved foot function and showed favorable cost-effectiveness, with ICERs ranging from (USD) $5.37-$148.71 per improvement in different outcomes. There is a high likelihood of cost-effectiveness for improving DPN symptoms and severity, foot pain, and function, even when the minimum willingness-to-pay threshold was set at $1000.00 USD. However, the intervention did not prove to be cost-effective in terms of QALYs. This study reveals SOPeD's effectiveness in reducing foot pain, improving foot function, and demonstrating cost-effectiveness in enhancing functional and clinical outcomes. SOPeD stands as a potential game-changer for modifiable risk factors for ulcers, with our findings indicating a feasible and balanced integration into public health systems. Further studies and considerations are vital for informed decisions to stakeholders and the successful implementation of this preventive program on a larger scale.Trial Registration: ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

Knowledge, attitudes and practices on diabetic foot care among nurses in Kimberley, South Africa.

BACKGROUND:  Diabetic foot is a dangerous complication of diabetes and can lead to high morbidity and mortality. As essential team members of the healthcare system, nurses play an important role in diabetic foot management and are indispensable in patients' education to prevent diabetic foot. The study assessed nurses' knowledge, attitudes and practices regarding diabetic foot care in Sol Plaatje primary health care centres in the Northern Cape: Sol Plaatje's 14 district municipality clinics, Kimberley, Northern Cape. METHODS:  This was a descriptive cross-sectional analytical study. A questionnaire assessed nurses' knowledge, practices and attitudes towards diabetic foot care in the above setting. RESULTS:  A total of 128 professionals, enrolled and auxiliary nurses who are providing primary care to patients within the 14 clinics in the Sol-Plaatje sub-district were recruited for the study. Hundred and five participants completed the self-administered questionnaires. The majority (95%) were females and 58.1% knew that South African Diabetic Foot Guidelines existed, while 57.7% had read them. About 57% did not know about the 60-s diabetic foot screening tool, and 67% did not know the 10 g monofilament test. Approximately 29.8% had never attended a class on diabetic foot care and 85.6% required training on diabetic foot care. CONCLUSION:  This study revealed that the majority of nurses working in the Sol-Plaatje sub-district primary health care centres are knowledgeable of the diabetic foot guidelines for primary care. However, there is a need for ongoing education on diabetic foot care.Contribution: The study results will help improve nurses' awareness of the importance of diabetic foot care.

Relaxation intervention to improve diabetic foot ulcer healing: protocol for a pilot study with a nested qualitative study.

OBJECTIVE: A mixed-methods approach nested in a pilot three-arm randomised controlled trial (RCT) was conducted to evaluate the feasibility and acceptability of an intervention of progressive muscle relaxation with guided imagery (experimental group) compared to a neutral guided imagery placebo (active control group) and a group that did not receive any psychological intervention (passive control group). The purpose was to inform a future definitive RCT that will test its effectiveness. Qualitatively, this study examined patients and health professionals' perspectives regarding the relaxation intervention, in order to assess the acceptability and applicability of relaxation as an adjuvant therapy. METHOD: Participants must have had a diagnosis of diabetes and diabetic foot disease; one or two active hard-to-heal ulcers at the time of the assessment; and clinical levels of stress or anxiety or depression. Participants were randomised and assessed at three timepoints after the first hospital consultation for hard-to-heal diabetic foot ulcer (DFU). RESULTS: Rates of eligibility, recruitment, refusal, adherence to study protocol, participation in follow-up and dropout, and patients' satisfaction with the relaxation intervention were assessed as primary outcomes. Secondary outcomes were DFU healing; patients' DFU-related quality of life; physical and mental quality of life; perceived stress; emotional distress; adherence to DFU care; perceptions of DFU; as well as arterial systolic/diastolic pressure and heart rate. CONCLUSION: The results of this pilot study contributed to clarification and better elucidation of the benefits of relaxation techniques regarding patients' HRQoL and DFU healing. DECLARATION OF INTEREST: Funding: This study was conducted at the Psychology Research Centre (CIPsi/UM) School of Psychology, University of Minho, Portugal and supported by the Foundation for Science and Technology (FCT) through the Portuguese State Budget (UIDB/01662/2020) and by a PhD fellowship from FCT assigned to GF (SFRH/BD/131780/2017) and an FCT grant (PTDC/PSI-GER/28163/2017) assigned to MGP. The authors have no conflicts of interest to declare.

Efficacy of autologous platelet-rich plasma gel in patients with hard-to-heal diabetic foot ulcers: a multicentre study in Japan.

OBJECTIVE: To evaluate the healing outcome of a platelet-rich plasma (PRP) gel prepared using TKKT01 (a wound care device to prepare the PRP gel) in patients with hard-to-heal diabetic foot ulcers (DFUs) and who showed an inadequate response to ≥4 weeks of standard of care (SoC). METHOD: This open-label, single-arm, multicentre study was conducted in 15 centres in Japan. Eligible patients received PRP gel treatment twice a week for eight weeks, followed by a final evaluation after the completion of week 8 (day 57). The primary endpoint was the percentage of patients who achieved ≥50% reduction in wound radius at the final evaluation (achievement criterion, ≥60% of patients). Secondary endpoints included: wound area and volume reduction rates; time to possible wound closure by secondary intention; time to possible wound closure using a relatively simple procedure (e.g., skin graft and suture); and safety at the final evaluation. RESULTS: A total of 54 patients were included in the full analysis set, with 47 patients included in the per protocol set; the primary endpoint was met in 38/47 (80.9%) (95% confidence interval: 66.7-90.9%) patients who achieved ≥50% wound radius reduction at the final evaluation. High rates of wound area (72.8%) and volume (92.7%) reduction were observed at the final evaluation. The median time to possible wound closure by secondary intention and by use of a relatively simple procedure was 57 and 43 days, respectively. Complete wound closure at the final evaluation was achieved in 27 (57.4%) patients. No safety concerns were raised. CONCLUSION: In this study, the efficacy and safety of PRP gel treatment with TKKT01 in patients with hard-to-heal DFUs in Japan were confirmed by our findings. DECLARATION OF INTEREST: This study was funded by Rohto Pharmaceutical Co., Ltd., Japan. NO has been paid a consulting fee by Rohto Pharmaceutical Co., Ltd. KH is the Chief Medical Officer of Rohto Pharmaceutical. Co., Ltd. The other authors have no conflict of interest to declare.

Dehydrated Amnion Chorion Membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial.

OBJECTIVE: Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. This prospective, multicentre, randomised controlled trial (RCT) evaluated the effectiveness of a dehydrated Amnion Chorion Membrane (dACM) (Organogenesis Inc., US) versus standard of care (SoC) alone in complex DFUs in a challenging patient population. METHOD: Subjects with a DFU extending into dermis, subcutaneous tissue, tendon, capsule, bone or joint were enrolled in a 12-week trial. They were allocated equally to two treatment groups: dACM (plus SoC); or SoC alone. The primary endpoint was frequency of wound closure determined by a Cox analysis that adjusted for duration and wound area. Kaplan-Meier analysis was used to determine median time to complete wound closure (CWC). RESULTS: The cohort comprised 218 patients, and these were split equally between the two treatment groups with 109 patients in each. A Cox analysis showed that the estimated frequency of wound closure for the dACM plus SoC group was statistically superior to the SoC alone group at week 4 (12% versus 8%), week 6 (22% versus 11%), week 8 (31% versus 21%), week 10 (42% versus 27%) and week 12 (50% versus 35%), respectively (p=0.04). The computed hazard ratio (1.48 (confidence interval: 0.95, 2.29) showed a 48% greater probability of wound closure in favour of the dACM group. Median time to wound closure for dACM-treated ulcers was 84 days compared to 'not achieved' in the SoC-treated group (i.e., ≥50% of SoC-treated DFUs failed to heal by week 12; p=0.04). CONCLUSION: In an adequately powered DFU RCT, dACM increased the frequency, decreased the median time, and improved the probability of CWC when compared with SoC alone. dACM demonstrated beneficial effects in DFUs in a complex patient population. DECLARATION OF INTEREST: This study was funded by Organogenesis Inc., US. JC serves as a consultant and speaker for Organogenesis. RDD serves as a speaker for Organogenesis. OMA and MLS serve as consultants for Organogenesis. The authors have no other conflicts of interest to declare.

Effects of neuromuscular taping form I on wound temperature and erythema in diabetic foot ulcer: a preliminary study.

OBJECTIVE: This study aimed to measure the effectiveness of neuromuscular taping (NMT) form I (a polyacrylate tape 0.6cm wide and 30cm long) on wound temperature and erythema in diabetic foot ulcers (DFUs) as an initial study in NMT intervention trials. METHOD: The study employed a quasi-experimental pretest and post-test design with a seven-day observation. The research sample was 38 patients with DFU grades 2 and 3. The sample was divided into two groups: the control group (n=19) and the intervention group (n=19). In wound care, the modern dressing was applied to both groups while NMT was applied to the intervention group in form I with 30cm long and 6mm wide strips, and on the proximal, distal and lateral sides. The wound bed temperature was measured with a non-contact infrared thermometer, and erythema was measured with Corel Photo-Paint X5 software (Corel Corp, Canada). Statistical analysis between the two groups was carried out using the Mann-Whitney test, independent t-test and Chi-squared test with p< 0.05 representing statistical significance. RESULTS: The preliminary results revealed that no statistically significant differences (p>0.05) were noted between the groups in sociodemographic or clinical characteristics, including age, body mass index, blood sugar, duration of diabetes, sex, smoking history, wound temperature and degree of erythema. Finally, it was also observed that, after seven days of application, NMT form I increased wound bed temperature, and reduced the level of erythema (p<0.05). CONCLUSION: In this study, NMT form I has been shown to increase the wound bed temperature and reduce the degree of erythema in DFUs.

Patients' behaviour after referral to a wound care clinic for diabetic foot ulcer care: a grounded theory study.

OBJECTIVE: The aim of this study was to construct a grounded theory regarding patients' activity behaviour over time after referral to an outpatient clinic for diabetic foot ulcer (DFU) care. METHOD: A constructivist grounded theory approach was used. Data from observations of and interviews with participants were collected and analysed using the constant comparative method. Based on this, the grounded theory 'Just a bump in the road' was constructed. RESULTS: The cohort included five participants who considered their ulcers as 'Just a bump in the road' in their lives, and four subcategories were embedded in this core category: 'Restricting my freedom'; 'Trusting or doubting the system'; 'Feeling no pain or illness'; and 'Receiving insufficient information'. Together, these categories describe the participants' behaviour and underlying concerns related to daily activities after referral to an outpatient clinic for the care of their DFU. CONCLUSION: The grounded theory 'Just a bump in the road' describes how participants with a DFU viewed their condition as merely a passing phase that would end with them regaining what they considered a normal life. Integrating these results into clinical practice could lead to improved care and a focus shift among health professionals from viewing patients as being defined by their wounds to seeing them as people who live with a wound.

Use of carbon dioxide fractional laser in the management of lower limb ischemia in patients with diabetes: a case report : CO2 fractional laser in the treatment of diabetic foot.

Treatment of lower limb ischemia in patients with diabetes is challenging because of the location of the ulcers and the complexity of their pathogenesis. Carbon dioxide fractional laser (CO2FL) therapy in conjunction with tibial periosteum distraction could become a substitute for conventional methods. We herein describe a patient diagnosed with ischemic diabetic foot with a complex ulcer in the upper third of the tibia. Laser irradiation (Deep FX mode with 30 mJ of energy and 10% density) was applied to the entire region of skin below the knee after surface anesthesia, and this treatment was performed twice a week until the ulcer healed. Computed tomography angiography showed successful establishment of a blood supply to the back of the right foot after treatment. Skin grafting was successfully performed, with only a few wounds remaining on the foot 8 months after treatment. The pain score was significantly decreased at the last follow-up. No complications occurred. This case report provides guidance for the performance of CO2FL, a fast, easy, accurate treatment in patients with diabetes. CO2FL can target lower limb arterial occlusive disease accompanied by refractory ulcers, addressing the underlying vascular occlusion and dysfunction as well as promoting microcirculation and wound healing.

Clinical perspectives on sampling and processing approaches for the management of infection in diabetic foot ulceration: A qualitative study.

Diabetic foot ulcers (DFUs) often become infected and are treated with antimicrobials, with samples collected to inform care. Swab samples are easier than tissue sampling but report fewer organisms. Compared with culture and sensitivity (C&S) methods, molecular microbiology identifies more organisms. Clinician perspectives on sampling and processing are unknown. We explored clinician perspectives on DFU sampling-tissue samples/wound swabs-and on processing techniques, culture and sensitivity or molecular techniques. The latter provides information on organisms which have not survived transport to the laboratory for culture. We solicited feedback on molecular microbiology reports. Qualitative study using semi-structured interview, with analysis using a Framework approach. CODIFI2 clinicians from UK DFU clinics. Seven consultants agreed to take part. They reported, overall, a preference for tissue samples over swabbing. Clinicians were not confident replacing C&S with molecular microbiology as the approach to reporting was unfamiliar. The study was small and did not recruit any podiatrists or nurses, who may have discipline-specific attitudes or perspectives on DFU care. Both sampling approaches appear to be used by clinicians. Molecular microbiology reports would not be, at present, suitable for replacement of traditional culture and sensitivity.

Advances in Chronic Wound Management: From Conventional Treatment to Novel Therapies and Biological Dressings.

Chronic wounds can be classified as diabetic foot ulcers, pressure ulcers, or venous leg ulcers. Chronic wound management has become a threat to clinicians and constitutes a major healthcare burden. The healing process of chronic wounds requires many factors to work in concert to achieve optimal healing. Various treatment options, ranging from hypoxia to infection, have evolved considerably to address the challenges associated with chronic wound healing. The conventional and accelerating treatments for chronic wounds still represent an unmet medical need due to the complex pathophysiology of the chronic wound microenvironment. In clinical settings, traditional chronic wound care practices rely on nonspecific topical treatment, which can reduce pain and alleviate disease progression with varying levels of success but fail to completely cure the wounds. Conventional wound dressings, such as hydrocolloids, gauze, foams, and films, have also shown limited success for the treatment of chronic wounds and only act as a physical barrier and absorb wound exudates. Emerging advances in treatment approaches, including novel therapies (stem cells, microRNAs, and nanocarrier-based delivery systems) and multifunctional biological dressings, have been reported for chronic wound repair. This review summarizes the challenges offered by chronic wounds and discusses recent advancements in chronic wound treatment.

[The management of diabetic foot: the new guidelines of the International Working Group on Diabetic Foot]. / La gestione del piede diabetico: le nuove linee guida dell'International Working Group on Diabetic Foot.

. The management of diabetic foot: the new guidelines of the International Working Group on Diabetic Foot. The publication of the new guidelines on the diabetic foot are an opportunity for a fine-tuning of the (few) new developments, but of the soundness of the evidence and knowledge known so far. Compared to the previous 2019 guidelines, the 2023 update included the analysis of randomised clinical trials only, a more accurate application of the GRADE method, a leaner and more current bibliography, and an update of the strength of some recommendations from low to conditional. The real big news in the 2023 update is the publication of a specific guideline for the diagnosis and treatment of Charcot neuro-osteoarthropathy in people with diabetes, neuropathy and in the absence of skin lesions.

A prospective, open-label, nonrandomized clinical trial using polyvinyl alcohol antibacterial foam for debridement of diabetic foot ulcers.

BACKGROUND: Diabetic foot ulcers (DFUs) pose significant challenges for patients, often leading to chronic inflammation, reduced mobility, and chronic pain. Despite being less prevalent in the United States compared to other nations, the economic burden of DFUs remains substantial, with an estimated annual cost ranging from $9 billion to $13 billion. Furthermore, DFUs are a leading cause of nontraumatic lower extremity amputations and significantly impact health care systems and work productivity. OBJECTIVE: This study aimed to evaluate the effectiveness of a polyvinyl alcohol (PVA) foam dressing containing gentian violet/methylene blue (GV/MB) in managing chronic DFUs. MATERIALS AND METHODS: A single-center study was conducted involving 20 patients with full-thickness chronic lower extremity wounds, including DFUs. Patients received treatment with a PVA foam dressing with GV/MB applied in an outpatient setting over a period of 4 weeks. Wound size, bacterial presence, and healing progress were assessed using fluorescence imaging and wound measurements. RESULTS: The study included 13 males and 7 females with an average age of 64.2 years. After 4 weeks of treatment, the average DFU size decreased by 53%, with 4 patients achieving complete wound closure. Reduction in ulcer size was strongly correlated with the use of surgical debridement and PVA GV/MB foam. Fluorescence imaging demonstrated a significant reduction in bacterial presence in all patients by the end of the study. Follow-up at 3 and 6 months showed no recurrent ulcerations, indicating the potential for long-term efficacy. CONCLUSION: The findings suggest that PVA GV/MB foam dressings, when combined with surgical debridement, are effective in promoting the healing of chronic DFUs. Further research with larger, controlled studies is warranted to confirm these findings and assess cost-effectiveness.

Dual Drug-Loaded Coaxial Nanofiber Dressings for the Treatment of Diabetic Foot Ulcer.

Introduction: Diabetes mellitus is frequently associated with foot ulcers, which pose significant health risks and complications. Impaired wound healing in diabetic patients is attributed to multiple factors, including hyperglycemia, neuropathy, chronic inflammation, oxidative damage, and decreased vascularization. Rationale: To address these challenges, this project aims to develop bioactive, fast-dissolving nanofiber dressings composed of polyvinylpyrrolidone loaded with a combination of an antibiotic (moxifloxacin or fusidic acid) and anti-inflammatory drug (pirfenidone) using electrospinning technique to prevent the bacterial growth, reduce inflammation, and expedite wound healing in diabetic wounds. Results: The fabricated drug-loaded fibers exhibited diameters of 443 ± 67 nm for moxifloxacin/pirfenidone nanofibers and 488 ± 92 nm for fusidic acid/pirfenidone nanofibers. The encapsulation efficiency, drug loading and drug release studies for the moxifloxacin/pirfenidone nanofibers were found to be 70 ± 3% and 20 ± 1 µg/mg, respectively, for moxifloxacin, and 96 ± 6% and 28 ± 2 µg/mg, respectively, for pirfenidone, with a complete release of both drugs within 24 hours, whereas the fusidic acid/pirfenidone nanofibers were found to be 95 ± 6% and 28 ± 2 µg/mg, respectively, for fusidic acid and 102 ± 5% and 30 ± 2 µg/mg, respectively, for pirfenidone, with a release rate of 66% for fusidic acid and 80%, for pirfenidone after 24 hours. The efficacy of the prepared nanofiber formulations in accelerating wound healing was evaluated using an induced diabetic rat model. All tested formulations showed an earlier complete closure of the wound compared to the controls, which was also supported by the histopathological assessment. Notably, the combination of fusidic acid and pirfenidone nanofibers demonstrated wound healing acceleration on day 8, earlier than all tested groups. Conclusion: These findings highlight the potential of the drug-loaded nanofibrous system as a promising medicated wound dressing for diabetic foot applications.