Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers
brief summary
The main objective of this study is: To assess the safety of EscharEx (EX-03 5% formulation) compared to placebo control and compared to Collagenase (NSSOC) in patients with VLU.
detailed description
At least 45 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 or with Collagenase in unblinded manner.
Total duration of the study is up to 15 weeks:
Screening period (2 visits, 7 days apart), Daily Visits Period - Debridement with IMP (up to 8 daily site visits within up to 2 weeks), Weekly Visits Period - wound management (up to 11 visits within up to 10 weeks) + optional wound closure confirmation (up to 2 weeks). Wound will be managed in a standardized manner.
official title
A Multicenter, Prospective, Randomized, Placebo and Collagenase (Non-surgical Standard-of-care) Controlled Study, Performed to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase in Patients With Venous Leg Ulcers