This is a pharmacokinetics (PK) study - the main objective of this study is to assess the PK, safety and clinical performance of 5% EscharEx (EX-03 formulation) in debridement of Venous Leg Ulcers
Men or women, older than 18 years of age,
Participants 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 2 years,
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, is 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,
Participants 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 2 cm and 5 cm away from the edge of the target wound,
Severely damaged skin (e.g., abrasion, erosion, exfoliation) extending >2 cm around the wound's edge,
Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,
MediWound Ltd
Lead sponsor
TFS HealthScience
Collaborator