Hunter H Sams1, June Chen, Lloyd E King. 1. Department of Medicine (Dermatology), Vanderbilt University and Nashville Veteran's Administration Hospital, Nashville, Tennessee, USA.
Abstract
BACKGROUND: Chronic diabetes-related foot ulcers result from predisposition, tissue injury, and inadequate reparative mechanisms. Standard care for diabetes-related foot ulcers includes weight off-loading, pressure-relieving footwear, aggressive surgical debridement, and frequent dressing changes. Graftskin is a recently developed living skin construct. OBJECTIVE: To compare Graftskin and standardized wound care to standardized wound care alone in the treatment of difficult to heal diabetes-related neuropathic foot ulcers, and to assess the handling and application characteristics of Graftskin. METHODS: A university dermatology clinic was part of a 24-center prospective, randomized, controlled, parallel group comparative trial of Graftskin for the treatment of difficult to heal neuropathic diabetes-related foot ulcers. Patients were randomly assigned to treatment with Graftskin with aggressive debridement and standardized wound care, or aggressive debridement and standardized wound care alone. Blinding was not feasible due to device visibility during application. RESULTS: Five of nine patients (56%) treated with Graftskin therapy had complete healing. Three of eight control patients (37%) had complete healing. CONCLUSION:Graftskin as an adjunct to aggressive debridement and standardized wound care appears to be a valuable treatment adjunct in patients with difficult to heal diabetes-related neuropathic foot ulcers. The application learning curve was steep and the ease of application exceptional.
RCT Entities:
BACKGROUND: Chronic diabetes-related foot ulcers result from predisposition, tissue injury, and inadequate reparative mechanisms. Standard care for diabetes-related foot ulcers includes weight off-loading, pressure-relieving footwear, aggressive surgical debridement, and frequent dressing changes. Graftskin is a recently developed living skin construct. OBJECTIVE: To compare Graftskin and standardized wound care to standardized wound care alone in the treatment of difficult to heal diabetes-related neuropathic foot ulcers, and to assess the handling and application characteristics of Graftskin. METHODS: A university dermatology clinic was part of a 24-center prospective, randomized, controlled, parallel group comparative trial of Graftskin for the treatment of difficult to heal neuropathic diabetes-related foot ulcers. Patients were randomly assigned to treatment with Graftskin with aggressive debridement and standardized wound care, or aggressive debridement and standardized wound care alone. Blinding was not feasible due to device visibility during application. RESULTS: Five of nine patients (56%) treated with Graftskin therapy had complete healing. Three of eight control patients (37%) had complete healing. CONCLUSION: Graftskin as an adjunct to aggressive debridement and standardized wound care appears to be a valuable treatment adjunct in patients with difficult to heal diabetes-related neuropathic foot ulcers. The application learning curve was steep and the ease of application exceptional.