Open-label Venous Leg Ulcer Pilot Study Using a Novel Autolologous Homologous Skin Construct

Abstract

Background:. Venous leg ulcers (VLUs) are often refractory to compression therapy, and their prevalence is increasing. An autologous homologous skin construct (AHSC) that uses the endogenous regenerative capacity of healthy skin has been developed to treat cutaneous defects, with a single application. The ability of AHSC to close VLUs with a single treatment was evaluated in an open-label, single-arm feasibility study to test the hypothesis that AHSC treatment will result in wound closure by providing healthy autologous tissue to the wound bed. Methods:. Ten VLUs were treated with a single application of AHSC. A 1.5 cm2 full-thickness skin harvest from the proximal calf was collected and sent to a Food and Drug Administration–registered facility, where it was processed into AHSC and returned to the provider within 48 hours. AHSC was spread evenly across the wound and dressed with silicone. The primary endpoint was wound closure rate at 12 weeks. Wound closure was followed with 3-dimensional planimetry, and closure was confirmed by a panel of plastic surgeons. Additional endpoints followed for 12 weeks included graft take, harvest site closure, adverse event rate, complications, and patient-reported pain. Results:. All 10 VLUs demonstrated successful graft take as evidenced by graft persisting in wound and harvest site closure. Eight VLUs exhibited complete closure within 12 weeks. One VLU that failed to heal with a prior split thickness skin graft closed within 13.5 weeks with AHSC. The mean time of closure was 34 days (95% confidence interval, 14–53). Pain improved by closure confirmation visit. There was 1 serious adverse event unrelated to the product or procedure. Conclusion:. This pilot study demonstrated that AHSC may be a viable single-application topical intervention for VLUs and warrants further investigation in larger, controlled studies.