A Randomized Controlled Trial to Evaluate the Treatment of Diabetic Foot Ulcers with a Novel Autologous Heterogeneous Skin Construct

Introduction and Objective: A novel autologous heterogeneous skin construct (AHSC) has been developed for the repair and replacement of skin. A pilot study demonstrated the ability of AHSC to close diabetic foot ulcers (DFUs).1-3 A subsequent randomized controlled trial (RCT) (NCT03881254) was designed to investigate whether AHSC is a viable treatment for DFUs. The objective of this study is to present the topline data from the RCT comparing standard of care (SOC) plus AHSC to SOC alone. Methods: 102 patients with DFUs involving skin and subcutaneous tissues not involving bone, tendon, or capsule ranging in size from 1-25cm2 that failed at least 4 weeks of prior treatment were enrolled. Following consent to participate in the trial, patients underwent a 2-week run-in period of SOC treatment defined as a collagen-based primary layer covered with supportive dressings and offloading. Patients with ulcers that did not change in size by greater than 30% during the run-in period were randomized 1:1 to treatment with a single application of AHSC or continued SOC. Wounds were assessed by visual inspection, planimetry and blinded high-resolution digital photography. Following determination of closure by the treating investigator, a blinded-panel of adjudicators confirmed wound closure. Results: The primary endpoint was the percentage of ulcers healed at 12 weeks. Secondary endpoints were percent area reduction (PAR) at 4, 6, 8, and 12 weeks; improvement in quality of life using wound quality of life score; change in pain levels; and change in Semmes Weinstein monofilament testing. Graft take at each visit was assessed. Results from analysis of 102 enrolled subjects will be presented. Conclusions: This trial is designed to evaluate whether AHSC is a viable treatment for DFUs. Disclosures: The Professional Education and Research Institute, whose Medical Director is Charles Zelen DPM, FACFAS, received research support from PolarityTE to administer the randomized controlled trial. PolarityTE assisted in assembling this abstract.