Clinical Efficacy of a Contralateral Shoe Lift in Patients with Diabetic Foot Ulcers and Induced Limb-Length Discrepancies: A Randomized Controlled Trial.

Abstract

Objective: To evaluate the clinical efficacy of combining an offloading device with a contralateral shoe lift to compensate for induced limb-length discrepancies in participants with plantar diabetes-related foot ulcers. Approach: Between March 2021 and December 2023, 42 consecutive patients with active plantar diabetic foot ulcers (DFUs) were randomly assigned (1:1) to the treatment group (limb-length discrepancy compensation with a shoe lift in the therapeutic footwear of the contralateral limb) or a control group that did not receive limb-length discrepancy compensation. Primary outcomes included the 20-week wound-healing rate and wound area reduction. Secondary outcomes included minor amputation, new ulcers in the contralateral limb, perceived comfort, and hip pain. Results: On an intention-to-treat basis, 15 participants in the control and 19 in the treatment group showed ulcer healing (p = 0.0023). In those with >80% adherence to the offloading device, multivariate analysis showed that the shoe lifts improved ulcer healing time. The use of a shoe lift reduced the number of minor amputations and the occurrence of new ulcers in the contralateral limb (p = 0.035; p = 0.033 respectively). Hip pain and perceived comfort improved with the use of shoe lifts (p < 0.001). Innovation: It validates the use of shoe lifts for patients with DFUs, as it is the first largest study of its kind to establish a clear reference standard to guide clinician decision-making. Conclusion: The use of shoe lifts reduced healing time in participants with diabetes and active plantar foot ulcers. Shoe lifts reduce late complications, including new ulcers in the contralateral limb and minor amputations.