A Total Offloading Foot Brace for Treatment of Diabetic Foot Ulcers: Results From a Halted Randomized Controlled Trial

Introduction. Foot offloading is the mainstay treatment for plantar diabetic foot ulcers (DFUs). Objective. This multicenter, single-blinded, randomized controlled trial evaluates the efficacy of offloading a totalfoot brace for healing plantar DFUs. Materials and Methods. Seventeen patients were randomized to standard therapy(ie, reducing stress and pressure via mechanical offloading) or offloading foot brace. Comparison of plantar pressures was performed using digital pressure sensing films. The ulcers were assessed by physical inspection and digital planimetry of photographs.Results. Reductions in peak plantar pressures ranged from 67.3% to 89.4% (P = .09). Healing at weeks 12 to 15 had minimal differences (brace vs. control: 71.7% vs. 80.3%, respectively). Although not significant, earlier periods of the brace versus the control. demonstrated faster wound healing in weeks 2 to 5 (36.0% vs. 6.8%, respectively) and weeks 6 to 9 (50.7% vs. 17.0%, respectively). Conclusions. The total offloading foot brace minimizes plantar pressure, allowing for early healing of DFUs, and optimizations in brace design may enhance healing of plantar DFUs.