drugset / Trial / NCT04817228

A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers

NCT04817228

Phase 2 Completed 12 enrolled MediWound Ltd
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

EvaluationDrugModalityDoseRoute
Subject EscharEx Protein / enzyme biologic 5 % Topical

Indications