The International Working Group on the Diabetic Foot (IWGDF) has published evidence‐based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the use of offloading interventions to promote the healing of foot ulcers in people with diabetes and updates the previous IWGDF guideline. We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical‐scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, we recommend that a nonremovable knee‐high offloading device is the first choice of offloading treatment. A removable knee‐high and removable ankle‐high offloading device are to be considered as the second‐ and third‐choice offloading treatment, respectively, if contraindications or patient intolerance to nonremovable offloading exist. Appropriately, fitting footwear combined with felted foam can be considered as the fourth‐choice offloading treatment. If non‐surgical offloading fails, we recommend to consider surgical offloading interventions for healing metatarsal head and digital ulcers. We have added new recommendations for the use of offloading treatment for healing ulcers that are complicated with infection or ischaemia and for healing plantar heel ulcers. Offloading is arguably the most important of multiple interventions needed to heal a neuropathic plantar foot ulcer in a person with diabetes. Following these recommendations will help health care professionals and teams provide better care for diabetic patients who have a foot ulcer and are at risk for infection, hospitalization, and amputation.

Background Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers. Methods We updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient‐reported measures, and cost‐effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non‐controlled studies were summarised on a narrative basis. Results We identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta‐analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non‐controlled studies. Five meta‐analyses and 12 RCTs provided high‐quality evidence for non‐removable knee‐high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non‐removable knee‐high walkers were shown to be equally effective. Moderate‐quality evidence exists for removable knee‐high and ankle‐high offloading devices being equally effective in healing, but knee‐high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low‐quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non‐plantar ulcers, and neuropathic ulcers with infection or ischemia. Conclusion Strong evidence supports the use of non‐removable knee‐high offloading devices (either TCC or non‐removable walker) as the first‐choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee‐high or ankle‐high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high‐quality controlled studies are needed in these areas.

This study supports the validity of a modified version of OPUS for persons using different P&O devices, but also reveals limitations to be addressed in future studies. OPUS could be useful in clinical rehabilitation and research to evaluate P&O outcomes.

IntroductionTherapeutic shoes are prescribed to prevent diabetic foot ulcers, but adherence to wearing the shoes is often poor.AimThe aim of this study was to review the literature on factors that are associated with adherence to wearing therapeutic shoes and construct a model of adherence to aid future research and development in the field.MethodsWe conducted a systematic search in PubMed, CINAHL, and PsycINFO for quantitative studies on factors associated with adherence to wearing therapeutic shoes among people with diabetes.ResultsSix studies were included in the review. The studies focused mainly on patient-, therapy-, and condition-related adherence factors. There is some evidence (three to five studies) that sex, diabetes duration, and ulcer history are not associated with adherence. The evidence for or against the other factors was weak (only one or two studies) or conflicting.ConclusionThere is no conclusive evidence for using any factor to predict adherence to wearing therapeutic shoes, but there is some evidence against using certain factors for predicting adherence. Future studies should include a broader range of factors, including health system and social/economic factors, and they should investigate perceived costs and benefits of wearing therapeutic shoes in comparison with other shoes or no shoes. A seesaw model is presented illustrating the complex phenomenon of adherence. Further research is needed to identify factors associated with adherence to wearing therapeutic shoes, to enable the development of interventions to improve adherence and thereby reduce ulceration rates among people with diabetic foot complications.

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The Orthotics and Prosthetics Users' Survey modules are reliable and, thus, can be recommended for repeated measurements of patients over time. Relatively large changes are needed to achieve statistical significance when assessing individual patients.

AimsOffloading mechanical tissue stress is arguably the most important of multiple interventions needed to heal diabetes‐related foot ulcers. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence‐based guideline on offloading interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline.Materials and MethodsWe followed the GRADE approach by devising clinical questions and important outcomes in the PICO (Patient‐Intervention‐Control‐Outcome) format, undertaking a systematic review and meta‐analyses, developing summary of judgement tables and writing recommendations and rationales for each question. Each recommendation is based on the evidence found in the systematic review, expert opinion where evidence was not available, and a careful weighing of GRADE summary of judgement items including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability.ResultsFor healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, use a non‐removable knee‐high offloading device as the first‐choice offloading intervention. If contraindications or patient intolerance to non‐removable offloading exist, consider using a removable knee‐high or ankle‐high offloading device as the second‐choice offloading intervention. If no offloading devices are available, consider using appropriately fitting footwear combined with felted foam as the third‐choice offloading intervention. If such a non‐surgical offloading treatment fails to heal a plantar forefoot ulcer, consider an Achilles tendon lengthening, metatarsal head resection, joint arthroplasty, or metatarsal osteotomy. For healing a neuropathic plantar or apex lesser digit ulcer secondary to flexibile toe deformity, use digital flexor tendon tenotomy. For healing rearfoot, non‐plantar or ulcers complicated with infection or ischaemia, further recommendations have been outlined. All recommendations have been summarised in an offloading clinical pathway to help facilitate the implementation of this guideline into clinical practice.ConclusionThese offloading guideline recommendations should help healthcare professionals provide the best care and outcomes for persons with diabetes‐related foot ulcers and reduce the person's risk of infection, hospitalisation and amputation.

BackgroundOffloading treatment is crucial to heal diabetes‐related foot ulcers (DFU). This systematic review aimed to assess the effectiveness of offloading interventions for people with DFU.MethodsWe searched PubMed, EMBASE, Cochrane databases, and trials registries for all studies relating to offloading interventions in people with DFU to address 14 clinical question comparisons. Outcomes included ulcers healed, plantar pressure, weight‐bearing activity, adherence, new lesions, falls, infections, amputations, quality of life, costs, cost‐effectiveness, balance, and sustained healing. Included controlled studies were independently assessed for risk of bias and had key data extracted. Meta‐analyses were performed when outcome data from studies could be pooled. Evidence statements were developed using the GRADE approach when outcome data existed.ResultsFrom 19,923 studies screened, 194 eligible studies were identified (47 controlled, 147 non‐controlled), 35 meta‐analyses performed, and 128 evidence statements developed. We found non‐removable offloading devices likely increase ulcers healed compared to removable offloading devices (risk ratio [RR] 1.24, 95% CI 1.09–1.41; N = 14, n = 1083), and may increase adherence, cost‐effectiveness and decrease infections, but may increase new lesions. Removable knee‐high offloading devices may make little difference to ulcers healed compared to removable ankle‐high offloading devices (RR 1.00, 0.86–1.16; N = 6, n = 439), but may decrease plantar pressure and adherence. Any offloading device may increase ulcers healed (RR 1.39, 0.89–2.18; N = 5, n = 235) and cost‐effectiveness compared to therapeutic footwear and may decrease plantar pressure and infections. Digital flexor tenotomies with offloading devices likely increase ulcers healed (RR 2.43, 1.05–5.59; N = 1, n = 16) and sustained healing compared to devices alone, and may decrease plantar pressure and infections, but may increase new transfer lesions. Achilles tendon lengthening with offloading devices likely increase ulcers healed (RR 1.10, 0.97–1.27; N = 1, n = 64) and sustained healing compared to devices alone, but likely increase new heel ulcers.ConclusionsNon‐removable offloading devices are likely superior to all other offloading interventions to heal most plantar DFU. Digital flexor tenotomies and Achilles tendon lengthening in combination with offloading devices are likely superior for some specific plantar DFU locations. Otherwise, any offloading device is probably superior to therapeutic footwear and other non‐surgical offloading interventions to heal most plantar DFU. However, all these interventions have low‐to‐moderate certainty of evidence supporting their outcomes and more high‐quality trials are needed to improve our certainty for the effectiveness of most offloading interventions.