A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)

PHASE3RecruitingINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2027

Conditions
Venous Leg Ulcer (VLU)
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 (5)

11042

ACTIVE_NOT_RECRUITING

Northwell Health Comprehensive Wound Healing Center, Lake Success

76104

RECRUITING

JPS Health Network/Acclaim Multispecialty Clinic, Fort Worth

78229

RECRUITING

University of Texas Health Science Center at San Antonio, San Antonio

93710

NOT_YET_RECRUITING

Limb Preservation Platform, Inc, Fresno

94115

RECRUITING

Center for Clinical Research INC, San Francisco

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MediWound Ltd

INDUSTRY