Offloading orthotic insoles on healing of diabetic foot ulcers: a protocol for systematic review and meta-analysis.

Abstract

Diabetic foot ulcers (DFUs) are a complication of uncontrolled and long-standing diabetes, often associated with peripheral neuropathy, and can result in amputation, prolonged hospitalisation and reduced quality of life. Orthotic insoles are commonly used to redistribute plantar pressure, offload the ulcer site and potentially accelerate wound healing. This systematic review aims to evaluate the effectiveness of offloading insoles in the healing of DFUs, with a focus on ulcer size reduction, recovery time, pain management, pressure redistribution and limb function, such as balance. A secondary objective is to compare the effects of different insole materials on healing outcomes, including satisfaction level towards the insole and overall quality of life. A comprehensive literature search will be conducted in PubMed, MEDLINE, CINAHL and Google Scholar. Randomised controlled trials (RCTs) will be prioritised, while non-randomised studies that meet the eligibility criteria will also be considered. Studies published in English between 2000 and 2026 will be included. Eligible studies must assess the impact of orthotic insoles on DFUs, with outcome measures including pain intensity, pressure redistribution, wound healing and recovery time. Methodological quality will be assessed using the PEDro scale, while the Cochrane Risk of Bias tool (RoB 2) and the Risk of Bias in Non-randomised Studies of Interventions (ROBINS-I) will be applied as appropriate. Data will be extracted using a standardised form. This review does not require ethical approval. The results will be shared through publications in peer-reviewed journals and conference presentations. CRD420251145215.