Igal Kushnir
RedDress Ltd, Israel
Title: A PROSPECTIVE, OPEN-LABEL, UNCONTROLLED STUDY EVALUATED THE CLINICAL PERFORMANCE OF RD1 IN CHRONIC DIABETIC FOOT ULCERS AT THREE WOUND CARE CLINICS IN THE USA
Biography
Biography: Igal Kushnir
Abstract
Statement of the Problem: Chronic wounds stall in the infl ammatory phase of wound healing characterized by the presence of non-viable tissue, excessive bacterial burden, and the presence of increased infl ammatory cytokines. Th e RedDress Wound Care System (RD1; RedDress Ltd, Israel), is an autologous, biodegradable fi brin scaff old that recreates the functional wound healing environment with minimal risk of immunorejection. Th e primary objective of this study was to determine safety and effi cacy of the RD1 in the treatment of diabetic foot ulcers (DFU). Methodology & Th eoretical Orientation: Following a screening period of 2 weeks, wounds were treated weekly for up to 12 weeks with the RD1. 20 subjects with 20 DFUs were enrolled at 3 sites in the USA. Two subjects were not compliant with the protocol, resulting in 20 subjects for the ITT (intent-to-treat) analysis and 18 for the PP (per protocol) analysis. Findings: Safety: Th e mean AE rate for both ITT and PP populations was 1.6. Effi cacy: Th e proportion of wounds completely healed in the ITT and PP populations was 13/20 (65%) and 13/18 (72%), respectively. Th ere were 4 occurrences of ulcer recurrence following initial healing, with 2 occurrences resulting in unhealed wounds (same for ITT and PP). Percentage area reduction (PAR) for the ITT population at 4 and 12 weeks was 61.3% and 66.6%, respectively; the fi gures for the PP population were comparable at 4 weeks but better at 12 weeks: 60.0%, and 76.1%, respectively. Mean time to heal in the ITT population was 59 days and 56 days in the PP population. Conclusion & Signifi cance: Th e study demonstrated the safety and effi cacy of the RD1 in treating DFUs and the use of a natural autologous blood clot as a mean to support healing in DFUs.