drugset / Trial / NCT04817228
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
NaSingle-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2021-04-21
- Primary completion
- 2022-05-06
- Completion
- 2022-05-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EscharEx | Protein / enzyme biologic | 5 % | Topical |