THE IMPACT OF CUSTOM 3D‐PRINTED FOOTWEAR ON DIABETIC FOOT ULCER HEALING: A RANDOMIZED CONTROLLED TRIAL

Abstract

Background: Diabetic foot ulcers (DFUs) are a leading cause of morbidity and limb loss in diabetes. Effective offloading of plantar pressure is critical for ulcer healing, yet patient adherence to bulky offloading devices is often poor[1][2]. This study evaluated a novel patient-specific 3D-printed footwear system designed to improve pressure offloading and patient acceptance.

Methods: We conducted a two-arm randomized controlled trial with 50 patients having neuropathic plantar DFUs (Wagner grade 1–2). Participants were randomly assigned to use either custom 3D-printed therapeutic footwear (intervention, n = 22) or standard Microcellular Rubber (MCR) therapeutic footwear (control, n = 28). All patients received identical wound care. The 3D-printed shoes were created via 3D foot scanning, computer-aided design (CAD) customization, and fused deposition modeling (thermoplastic polyurethane filament) to produce contoured, pressure-offloading insoles. Primary outcome was the proportion of ulcers healed (complete epithelialization) within 12 weeks. Secondary outcomes included time to healing, plantar pressure reduction, footwear adherence (measured by self-reported wear logs and periodic in-shoe sensors), patient-reported comfort/satisfaction, and any ulcer-related complications. Data were analyzed by intention-to-treat.

Results: Baseline characteristics (age ~57 years, 50% male, diabetes duration ~11.5 years) were similar between groups. The custom 3D-printed insoles achieved superior pressure offloading: in-shoe pressure mapping showed ~40% reduction in peak plantar pressures at high-risk sites compared to standard insoles[3]. Healing outcomes favored the 3D-printed footwear. By 12 weeks, 86.7% of patients in the 3D-printed group achieved complete ulcer healing, versus 77.1% in the standard group (p < 0.001). Median time to healing was shorter in the 3D group (≈9 weeks) than in controls (≈12 weeks). Patients wearing 3D-printed footwear demonstrated higher adherence, wearing their offloading shoes for an estimated 93% of daily hours vs 85% in the control group (p < 0.001). They also reported greater comfort and satisfaction (mean satisfaction score 8.45 vs 7.32 out of 10, p = 0.0004). Fewer ulcer-related complications (infection, new ulcers) were observed in the 3D group, though numbers were too small for robust statistical comparison. No device-related adverse events occurred.

Conclusions: Custom-fabricated 3D-printed footwear markedly improved DFU outcomes in this trial. The personalized 3D-printed shoes accelerated ulcer healing and enhanced patient adherence compared to standard therapeutic shoes. By combining effective plantar pressure relief with improved patient comfort, this innovative approach addresses both biomechanical and behavioral barriers in DFU care. The results suggest that patient-specific 3D-printed offloading footwear is a clinically beneficial and patient-friendly intervention for promoting diabetic foot ulcer healing. Further multicenter studies with longer follow-up are warranted to confirm long-term benefits and cost-effectiveness.