RecruitingVenous Leg Ulcer (VLU)
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: MediWound Ltd
You may qualify if…
- ✓ 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 inSightTM),
- ✓ 6. Patient understands the nature of the procedure, is able to adhere to the protocol regimen, and provides a written informed consent prior to any study procedure.
You may not qualify if…
- ✕ 1. Wound size that has decreased by \> 20% after 7 (+3/-1) days of the screening period,
- ✕ 2. Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2cm and 5cm away from the edge of the target wound,
- ✕ 3. Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,
- ✕ 4. Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending \>2 cm around the wound's edge,
- ✕ 5. Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,
- ✕ 6. Clinical suspicion of skin cancer (e.g., basal cell carcinoma (BCC), squamous cell carcinoma (SCC), melanoma, or sarcoma), near the target wound, which was not ruled out by biopsy,
- ✕ 7. Patients with skin disorders unrelated to the wound that are presented adjacent to the wound,
- ✕ 8. Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,
Where it's recruiting
California
Fresno · Los Angeles · San Francisco · Vista
Florida
Miami
Massachusetts
Boston
New Jersey
Newark
New York
Lake Success · Mineola · New York
Ohio
Circleville
Texas
Houston · San Antonio
Source: ClinicalTrials.gov · NCT06568627 · last updated 2026-04-02