A Prospective Study Performed to Evaluate the Clinical Performance (Debridement), Safety and Pharmacology Effect of EscharEx (EX-02 Formulation) in Patients With Lower Leg Ulcers (VLU and DFU)
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU). In addition, the pharmacology effect of EX-02 will be assessed. Lower leg ulcer size between 2 cm2 and 80 cm2 (surface area).
• Patients, men or women, between 18 and 90 years of age,
• Patients with a VLU (determined by medical history, physical examination or an ultrasound scan demonstrating venous insufficiency) or DFU (determined by medical history, and physical examination),
• Wound is present for at least 4 weeks but no longer than 2 years,
• The necrotic/slough/fibrin non-viable tissue area is at least 50% of wound area (assessed by clinical evaluation),
• Target wound surface area is in the range of 2-80 cm2,
• 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.