A Multicenter, Prospective, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of Venous Leg Ulcers (VALUE)
MediWound Ltd
Summary
The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).
Description
At least 216 eligible adult patients with VLU (with a surface area between 2 cm2 and 25 cm2, and wound age between 4 weeks and 12 months), will be randomized. The patients will be treated with IMP (either EX-03 5% or placebo) in a double blinded manner. Total duration of the study is up to 29 weeks: 1. Screening period (2 visits, 7 days apart), 2. Daily Visits Period - Debridement with IMP (up to 8 daily site visits within up to 2 weeks), 3. Weekly Visits Period - wound management (up to 13 visits within up to 12 weeks) + optional wound closure confirmation (up to 2 weeks). Wound will be man…