Effectiveness of offloading interventions for people with diabetes‐related foot ulcers: A systematic review and meta‐analysis

Abstract

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.

Diabetic Foot Ulcers

“…Pooled data from 14 randomized clinical trials (1083 patients) showed that nonremovable devices were associated with improved healing compared with removable devices (81.9% vs 66.1%; RR, 1.24; 95% CI, 1.09-1.41; P = .001). 58 A study of 20 patients wearing waistmounted activity monitors and device-mounted monitors reported that patients engaged in only 28% of their total daily activity while wearing the protective boot compared with when it was…”

“…60 Achilles tendon lengthening may reduce risk of ulcer recurrence (RR, 3.4; 95% CI, 1.4-8.2 [absolute rates not provided]) for plantar forefoot ulcers. 51,58 These studies are summarized in Table 3.…”

Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2023 update)

“…The accompanying systematic review identified 194 eligible studies, performed 35 meta-analyses and developed 17 summary of findings tables with 128 evidence statements to collectively address these questions. 11 Based on the systematic review and expert opinion of the group, 20 summary of judgement tables were completed (see Supporting Information S1) with 16 recommendations developed that addressed the clinical questions. A clinical pathway, using a diagrammatic overview and incorporating all 16 recommendations, summarises the recommended approach to offloading treatment to heal a DFU (Figure 1).…”

“…11,13,19 It also identified that more high-quality studies are needed to confirm the promising effects of other offloading interventions to heal DFUs, in order to better inform practitioners about effective treatments. 11,19 Over the past 4 years, a number of new trials have been performed in the area of offloading that add to the evidence base for treating people with DFU. [23][24][25][26][27][28][29] Ulcer healing is still recognised as the key critically important outcome for people with DFU.…”

Offloading and adherence through technological advancements: Modern approaches for better foot care in diabetes

“…[6][7][8][9] Removable offloading devices such as knee-high walkers are common alternatives that offer similar pressure reductions. 5,10 Despite this, their healing efficacy is lower, primarily due to poor patient adherence. 1,3,5,11,12 As a result, adherence to removable devices has become a highlighted area for future research in recent international guidelines.…”