About this trial
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).
Eligibility criteria
Qualifiers
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),
Disqualifiers
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,
Trial design
Treatments tested in this trial
- EscharEx (EX-03)
- Placebo (Gel vehicle)