Aims: Principles of wound management, including debridement, wound bed preparation, and newer technologies involving alternation of wound physiology to facilitate healing, are of utmost importance when attempting to heal a chronic diabetes‐related foot ulcer. However, the rising incidence and costs of diabetes‐related foot ulcer management necessitate that interventions to enhance wound healing of chronic diabetes‐related foot ulcers are supported by high‐quality evidence of efficacy and cost effectiveness when used in conjunction with established aspects of gold‐standard multidisciplinary care. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence‐based guideline on wound healing interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.Materials and Methods: We followed the GRADE approach by devising clinical questions and important outcomes in the Patient‐Intervention‐Control‐Outcome (PICO) format, undertaking a systematic review, developing summary of judgements tables, and writing recommendations and rationale for each question. Each recommendation is based on the evidence found in the systematic review and, using the GRADE summary of judgement items, including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability, we formulated recommendations that were agreed by the authors and reviewed by independent experts and stakeholders.Results: From the results of the systematic review and evidence‐to‐decision making process, we were able to make 29 separate recommendations. We made a number of conditional supportive recommendations for the use of interventions to improve healing of foot ulcers in people with diabetes. These include the use of sucrose octasulfate dressings, the use of negative pressure wound therapies for post‐operative wounds, the use of placental‐derived products, the use of the autologous leucocyte/platelet/fibrin patch, the use of topical oxygen therapy, and the use of hyperbaric oxygen. Although in all cases it was stressed that these should be used where best standard of care was not able to heal the wound alone and where resources were available for the interventions.Conclusions: These wound healing recommendations should support improved outcomes for people with diabetes and ulcers of the foot, and we hope that widescale implementation will follow. However, although the certainty of much of the evidence on which to base the recommendations is improving, it remains poor overall. We encourage not more, but better quality trials including those with a health economic analysis, into this area.

OBJECTIVE—This study was designed to test the safety, effectiveness, and costs of off-loading with a novel, off-the-shelf irremovable device in the management of diabetic foot ulceration (DFU).

Objective. The objective of this study was to assess the impact of a structured follow-up program on the incidence of diabetic foot ulceration (DFU) in high-risk diabetic patients. Research Design and Methods. A total of 1874 diabetic patients referred to the Diabetic Foot Unit of the University of Pisa were ranked based on the ulcerative risk score proposed by the International Consensus on Diabetic Foot. Out of 334 patients (17.8%) with a score ≥2, 298 accepted to participate in this prospective trial and were randomized into 2 groups: group A, which received standard treatment, and group B, in which the patients received, as a part of a structured prevention program, custom-made orthesis and shoes. Incidence of new DFUs was observed for no less than 1 year and in a subset of patients after 3 and 5 years, respectively. Incidence of new DFUs and recurrences were considered as primary endpoints to establish the effectiveness of the program; costs were also compared. Results. Among the patients enrolled in this follow-up analysis, 46% had neuropathy and deformities, 20% had previous ulceration, 25% had previous minor amputation, and 9% had neuro-osteoarthropathy. During the first 12-month follow-up, 11.5% of patients in group B developed a DFU compared with 38.6% in group A (P < .0001). In the extended follow-up, the cumulative incidence of ulcer in group B compared with group A was 17.6% versus 61% (P < .0001) after 3 years and 23.5% versus 72% (P < .0001) after 5 years, respectively. The net balance at the end of the follow-up was highly in favor of the prevention program, with a saving of more than €100 000 per year. Conclusions. The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU in diabetic patients who are at high ulcerative risk and its related costs.

OBJECTIVE—This study was designed to evaluate the histopathology of neuropathic ulcers and whether pressure relief could change such histological patterns. RESEARCH DESIGN AND METHODS—We compared neuropathic plantar ulcers tissue excised from 10 diabetic patients (group A) with those taken from 10 patients with comparable lesions and glycemic control after 20 days in a total contact cast (group B). Tissue specimens were blindly examined by two independent pathologists for hyperkeratosis, fibrosis, cutaneous annexes, capillaries, inflammation, cellular debris, and granulating tissue. For each parameter, quantification was obtained according to an arbitrary score: 0, absent; 1, present in 67% of the lesion. RESULTS—Patients in group B showed a marked reduction in ulcer size after 20 days of casting (P < 0.01). The histopathological features of the two groups markedly differed. Group A patients showed a predominance of inflammatory elements as well as matrix alterations, vessel disruptions, inflammation, and debris. Group B ulcers showed a shift toward a reparative pattern with prevalence of neoformed capillaries and fibroblasts. Semiquantitative analysis confirmed the prevalence of hyperkeratosis, fibrosis, inflammation, and cellular debris in group A patients (P < 0.05), whereas cutaneous annexes, capillaries, and granulating tissue were more prevalent in group B lesions (P < 0.01). CONCLUSIONS—These results indicate that pressure relief with a total contact cast is associated with changes in the histology of neuropathic foot ulcers, indicating reduction of inflammatory and reactive components and acceleration of reparative processes.

This randomized trial was done to test the effectiveness and safety of using a novel antiseptic solution (Dermacyn® Wound Care [DWC], Oculus Innovative Sciences, Petaluma, CA) in the management of the postoperative lesions on the infected diabetic foot. 40 patients with postsurgical lesions wider than 5 cm2 left open to heal by secondary intention were randomized into 2 groups. Group A was locally treated with DWC, whereas group B received povidone iodine as local medication, both in adjunct to systemic antibiotic therapy and surgical debridement if needed. Ischemia, renal failure, bilateral lesions, or immunodepression were considered as exclusion criteria. Patients were followed up weekly for 6 months. The primary endpoint was healing rate at 6 months, while secondary endpoints were healing time, time to achieve negative cultures, duration of antibiotic therapy, number of reinterventions, and adverse events. Healing rates at 6 months were significantly shorter in group A (90%) than in group B (55%; P < .01). The time taken for cultures to become negative and duration of antibiotic therapy were also significantly (P < .05) shorter in group A than in group B, whereas the number of reinterventions was significantly higher in group B (P < .05). No difference was noted in the adverse events except that for reinfections, which were more frequent in group B than in group A (P < .01). DWC is as safe as and more effective than standard local antiseptics in the management of wide postsurgical lesions in the infected diabetic foot.

Despite its efficacy in healing neuropathic diabetic foot ulcers (DFUs), total contact cast (TCC) is often underused because of technical limitations and poor patient acceptance. We compared TCC to irremovable and removable commercially available walking boots for DFU offloading. We prospectively studied 60 patients with DFUs, randomly assigned to 3 different offloading modalities: TCC (group A), walking boot rendered irremovable (i-RWD; group B), and removable walking boot (RWD; group C). Patients were followed up weekly for 90 days or up to complete re-epithelization; ulcer survival, healing time, and ulcer size reduction (USR) were considered for efficacy, whereas number of adverse events was considered for safety. Patients’ acceptance and costs were also evaluated. Mean healing time in the 3 groups did not differ (P = .5579), and survival analysis showed no difference between the groups (logrank test P = .8270). USR from baseline to the end of follow-up was significant (P < .01) in all groups without differences between the groups. Seven patients in group A (35%), 2 in group B (10%), and 1 in group C (5%) (Fisher exact test P = .0436 group A vs group C) reported nonsevere adverse events. Patients’ acceptance and costs were significantly better in group C (P < .05). Our results suggest that a walking boot was as effective and safe as TCC in offloading the neuropathic DFUs, irrespective of removability. The better acceptability and lesser costs of a removable device may actually extend the possibilities of providing adequate offloading. Level II, prospective comparative study.