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A total offloading foot brace for treatment of diabetic foot ulcers: results from a halted randomized controlled trial
Johnson DJ, Saar BJ, Shevitz AJ, Kim AH, Hammer L, Kendrick DE, Moorehead P, Kashyap VS
Wounds 2018 Jul;30(7):182-185
clinical trial
2/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 a total offloading foot 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 = 0.09). Healing at weeks 12 to 15 had minimal differences (brace versus control: 71.7% versus 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% versus 6.8%, respectively) and weeks 6 to 9 (50.7% versus 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.

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