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).
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 18 months,
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),
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,
Parallel
EscharEx (EX-03)
Druga 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.
Placebo (Gel vehicle)
DrugA 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
Incidence of complete debridement, clinically (visually) assessed after each application
counting events of complete debridement
Facilitation of wound closure, clinically assessed, as measured by time to complete wound closure
counting events of complete wound closure until completion of weekly visits
Incidence of complete healthy viable granulation tissue, as assessed clinically
counting events of complete granulation
Time to the first declaration of complete debridement, clinically assessed
count in days
Time to Wound Bed Prepared, clinically assessed
Number of events counted in days
Incidence of complete wound closure, clinically assessed,
count of number of events
Incidence and severity of systemic and local adverse events
Incidence of target wound infections
counting events
Incidence of discontinuation due to adverse events
counting events of discontinuation
Change in pain, as assessed by Numeric Pain Rating Scale (NPRS)
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