The objectives of this study are:
* To evaluate the safety of EscharEx and its placebo Gel Vehicle compared to non-surgical standard of care (NSSOC) * To assess the efficacy of EscharEx (EX-03 5% formulation) compared to placebo control and compared to NSSOC.
Men or women, older than 18 years of age,
Participants with 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 sterile saline or water and mild soap, is at least 50% of the wound area (assessed by clinical evaluation),
Wound size decreased by >20% after 7 (+3/-1) days of the screening period,
Participants with more than one leg ulcer8, on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2 cm and 5 cm away from the edge of the target wound,
Signs of infection of the wound or peri-wound including purulent discharge, deep-tissue abscess, cellulitis, erysipelas, 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
Non-surgical standard of care (NSSOC)
Other interventionVarious dressings and Collagenase
Incidence (number of patients) of systemic and local adverse events (AEs) throughout the trial
The endpoint will assess number of patients, in each arm, with reported systemic and local AEs
Number of patients with Clinically significant changes in vital signs during the Daily Visits Period,
Number of patients with Clinically significant changes in vital signs
Number of patients with Clinically significant changes in clinical laboratory parameters
Number of patients with Clinically significant changes in clinical laboratory parameters
Time to complete wound closure
The outcome will assess time to reaching complete wound closure
Incidence of complete debridement
the outcome will assess number of patients with complete debridement assessed clinically
Incidence of complete healthy viable granulation tissue
the outcome will assess number of patients with complete healthy viable granulation tissue on the treated wound, assessed clinically
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This trial is not recruiting at the moment. You can still explore other options:
