A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement… (NCT06568627) | Clinical Trial Compass
RecruitingPhase 3
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
United States216 participantsStarted 2025-06-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men or women, older than 18 years of age,
✓. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),
✓. Wound is present for at least 4 weeks but no longer than 1 year,
✓. 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),
✓. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),
✓. 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.
Exclusion criteria
✕. Wound size that has decreased by \> 20% after 7 (+3/-1) days of the screening period,
✕. 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,
✕. Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,
✕. Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending \>2 cm around the wound's edge,
✕. Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,
What they're measuring
1
Incidence of complete debridement, clinically (visually) assessed after each application
Timeframe: up to 2 weeks
2
Facilitation of wound closure, clinically assessed, as measured by time to complete wound closure
✕. 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,
✕. Patients with skin disorders unrelated to the wound that are presented adjacent to the wound,
✕. Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,