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
MediWound Ltd
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men or women, older than 18 years of age, 2. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency), 3. Wound is present for at least 4 weeks but no longer than 1 year, 4. The necrotic/slough/fibrin non-viable tissue area is at least 50% of the wound area (assessed by clinical evaluation), 5. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM), 6. Patient understands the nature of the procedure, is able to adhere to the protocol regimen, and provides a…
Interventions
- DrugEscharEx (EX-03)
a sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the wound area.
- DrugPlacebo (Gel vehicle)
A sterile powder containing excipients only (no proteolytic enzymes). The powder and sterile water are mixed to form a gel prior to application on the wound area
Locations (2)
- ILD Research CenterCarlsbad, California
- Wojskowy Instytut MedycznyWarsaw