Endocrinology · Medical Literature
Comparing the Effectiveness of Different Types of Orthoses in Preventing Diabetic Foot Ulcer Recurrence: A Systematic Review of Randomized Clinical Trials.
Abstract
Therapeutic orthoses, such as medical shoes and custom insoles, are used to prevent diabetic foot ulcer (DFU) recurrence. This systematic review with narrative synthesis aimed to evaluate the effectiveness of orthoses in preventing DFU recurrence compared to standard care. We followed PRISMA guidelines for a systematic review. Searches were conducted in PubMed, Cochrane, and Web of Science. RCTs on orthoses for preventing DFU recurrence were included. Risk of bias was assessed using Cochrane tools. Due to heterogeneity, narrative synthesis was used. An initial search of 4166 articles identified ten randomized controlled trials (RCTs) that met the inclusion criteria and were included in this review, focusing on patients living with diabetes at risk of DFU recurrence compared to usual care. Narrative synthesis of the 10 RCTs, involving 1686 participants, showed that custom orthoses reduced recurrence in several studies (e.g., Bus 2013 reported 9.9% recurrence vs. 25% in controls), though the evidence was heterogeneous due to variability in orthosis types and follow-up periods. Orthoses can prevent diabetic foot ulcer recurrence, and we recommend their use where feasible. Further research is needed to optimize their clinical application.
Clinical relevance
In patients with diabetes who have a history of diabetic foot ulcers and are at risk of recurrence, are therapeutic orthoses (medical shoes, custom insoles) more effective than standard care in preventing diabetic foot ulcer recurrence? __SNAPSHOT__ {"studyDesign":"Systematic review with narrative synthesis of randomized controlled trials (PRISMA-compliant); meta-analysis was not performed due to clinical and methodological heterogeneity","setting":"Multi-database search (PubMed, Cochrane, Web of Science); individual RCTs were conducted in various clinical settings not individually specified in the abstract","sampleSize":"n=1,686 participants across 10 included RCTs","population":"Patients with diabetes mellitus at elevated risk of diabetic foot ulcer (DFU) recurrence; specific inclusion criteria (e.g., neuropathy severity, ulcer classification, IWGDF risk category) not detailed in the abstract","intervention":"Therapeutic orthoses including custom insoles, medical/therapeutic footwear, and related offloading devices","comparator":"Usual care (standard footwear or non-optimized custom footwear, depending on individual trial design)","primaryOutcome":"Diabetic foot ulcer recurrence rate","followUp":"Variable across included RCTs; specific range not reported in the abstract","fundingSource":"Not reported"}
Key findings
The narrative synthesis of 10 RCTs (n=1,686 total participants) suggested that custom orthoses reduced DFU recurrence in several of the included studies. As a representative example, the authors cite Bus 2013, which reported a recurrence rate of 9.9% in the orthosis group vs. 25% in controls — however, this figure requires important contextual clarification: the Bus 2013 RCT (Diabetes Care, 2013; n=171 neuropathic diabetic patients) compared offloading-improved custom footwear to usual-care custom footwear and, on intention-to-treat analysis, found 38.8% vs. 44.2% recurrence (OR 0.80, 95% CI 0.44–1.47, P=0.48), a non-significant result. A significant benefit was demonstrated only in the high-adherence subgroup (25.7% vs. 47.8%; OR 0.38, 95% CI 0.15–0.99, P=0.045). The specific figures cited in the abstract (9.9% vs. 25%) are not reconcilable with the published ITT or per-protocol results of Bus 2013 based on available full-text data, and no explanation is provided in the abstract; clinicians should treat these figures with caution until the full review text can be consulted. Because of study heterogeneity across orthosis types, follow-up durations, and comparator definitions, no pooled meta-analytic estimate (relative risk, odds ratio, NNT, or NNH) was calculable; none is reported in the abstract. Adverse event data are not reported in the abstract.
Practice implications
This systematic review provides low-to-moderate certainty evidence, consistent with prior literature, that custom therapeutic orthoses can reduce DFU recurrence compared to usual care in certain populations — particularly when orthoses are pressure-optimized and worn with high adherence. The review did not establish superiority of any single orthosis type, nor did it produce a pooled quantitative effect estimate, limiting its ability to guide precise clinical decision-making. The findings are most applicable to patients with diabetes who have a history of plantar foot ulceration and documented peripheral neuropathy; patients with primarily ischemic ulcers, Charcot arthropathy as the sole deformity, or severe peripheral arterial disease were likely not the primary subjects of included RCTs. Patients in lower-resource settings where custom orthoses are not feasible are also underrepresented. A critical determinant of benefit across this literature — patient adherence to wearing prescribed footwear — is widely recognized but not quantified in the abstract. The authors recommend orthosis use where feasible and call for further research; this is consistent with the 2023 IWGDF Prevention Guideline, which conditionally recommends pressure-optimized therapeutic footwear for high-risk patients. IMPORTANT CAVEAT: Only the abstract was available for this summary. The discrepancy between the cited Bus 2013 figures (9.9% vs. 25%) and the published Bus 2013 ITT results warrants clarification upon full-text review before these specific numbers are used in clinical or educational contexts. __LIMITATIONS__ Narrative synthesis only — clinical and methodological heterogeneity across orthosis types, follow-up periods, comparator definitions, and patient populations precluded meta-analysis, limiting quantitative conclusions,Only 10 RCTs with a total of 1,686 participants were included; individual trials were likely underpowered for definitive conclusions on DFU recurrence, a relatively low-frequency binary outcome,The recurrence rates cited from Bus 2013 in the abstract (9.9% vs. 25%) do not appear to correspond to the published ITT results of that trial (38.8% vs. 44.2%), raising concerns about data extraction accuracy that cannot be resolved from the abstract alone,Patient adherence to orthosis use — a critical effect modifier identified in prior RCTs — is not addressed as an outcome or subgroup analysis in the abstract,Inclusion criteria for patients (e.g., neuropathy classification, IWGDF risk stratification, ulcer type) are not reported in the abstract, making it difficult to assess to whom the findings apply,Risk of bias assessment was performed using Cochrane tools, but results are not summarized in the abstract,Blinding of participants to orthosis type is inherently not possible in footwear trials, introducing performance and detection bias risk across all included RCTs,Follow-up duration variability across RCTs could systematically affect recurrence rates and comparability,Generalizability is uncertain for non-plantar ulcers, patients in regions where footwear use is culturally limited, or low-resource settings without access to custom fabrication,Funding sources for the systematic review and for individual included RCTs are not reported in the abstract, precluding assessment of industry influence __BOTTOM_LINE_CATEGORY__ confirmatory __BOTTOM_LINE__ This PRISMA-compliant systematic review of 10 RCTs (n=1,686) provides narrative evidence suggesting that custom therapeutic orthoses can reduce diabetic foot ulcer recurrence compared to standard care, with benefit appearing most robust when footwear is pressure-optimized and worn with consistent adherence. No pooled effect estimate was calculable due to heterogeneity, and specific recurrence figures cited from individual trials require verification against published sources. Clinicians may reasonably continue recommending pressure-optimized custom orthoses for high-risk patients with healed plantar DFUs, consistent with IWGDF guidance, while acknowledging that the magnitude of benefit depends substantially on adherence.