Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

December 30, 2027

Study Completion Date

September 30, 2028

Conditions
Venus Leg Ulcers
Interventions
DRUG

EscharEx (EX-03)

a 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.

DRUG

Placebo (Gel vehicle)

A 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

Trial Locations (2)

92009

ILD Research Center, Carlsbad

Unknown

Wojskowy Instytut Medyczny, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MediWound Ltd

INDUSTRY