Safety and Efficacy of Amniotic Membrane Implant in Venous Leg Ulcers

Abstract

Objective: To assess the safety and efficacy of amniotic membrane (AM) application in venous leg ulcers (VLU). Methodology: Design: non-controlled pre-post clinical trial. A unique AM fragment was placed on the ulcer in strict sterility conditions. Main outcome measures: total healing rate, percentage of ulcer area reduction and diurnal and nocturnal pain assessment. Control visits: at baseline and 1, 2, 3, 4 and 8 weeks after treatment. Results: Ten patients were recruited (79.6 years). 3 weeks after AM implant, pain had completely disappeared and ulcer area had reduced to nearly halved and, 8 weeks after AM implant, ulcer area was reduced in more than 80% and in two thirds of patients the ulcer was completely healed. No relevant side effects were observed. Conclusions: The present study brings new evidence reinforcing the idea that AM dressing is a safety and effective alternative to heal VLU