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…
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 adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and either sterile saline or water and mild soap, 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 inSightT…
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 (25)
- Limb Preservation Platform, IncFresno, California
- Angel City Research,IncLos Angeles, California
- Center for Clinical Research INCSan Francisco, California
- ILD Research CenterVista, California
- University of MiamiMiami, Florida
- Massachusetts General HospitalBoston, Massachusetts