RecruitingPhase 3NCT06568627

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

A Multicenter, Prospective, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of Venous Leg Ulcers (VALUE)


Sponsor

MediWound Ltd

Enrollment

216 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called EscharEx (EX-03) and a drug called Placebo (Gel vehicle) for people with venous leg ulcer (vlu). The study is currently recruiting participants at 25 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEscharEx (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.

DRUGPlacebo (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


Locations(25)

Limb Preservation Platform, Inc

Fresno, California, United States

Angel City Research,Inc

Los Angeles, California, United States

Center for Clinical Research INC

San Francisco, California, United States

ILD Research Center

Vista, California, United States

University of Miami

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Rutgers New Jersey Medical Center

Newark, New Jersey, United States

Northwell Health Comprehensive Wound Healing Center

Lake Success, New York, United States

NYU Langone Health Long Island - Research & Academic Center

Mineola, New York, United States

Mount Sinai West

New York, New York, United States

Cutting Edge Research LLC.,

Circleville, Ohio, United States

Clinical Trial Network Houston

Houston, Texas, United States

Woundcentrics, LLC

San Antonio, Texas, United States

Medical University of Graz

Graz, Austria

Medical University Wien

Vienna, Austria

Ruhr-University Bochum

Bochum, Germany

Städtisches Klinikum Dresden

Dresden, Germany

Wundzentrum Dermatologie Erlangen

Erlangen, Germany

DermaKiel - Allergie und Haut Centrum

Kiel, Germany

Asaf Harofeh (Shamir) Medical Center

Be’er Ya‘aqov, Israel

Kaplan Medical Center

Rehovot, Israel

MIKOMED Sp. z o.o.

Lodz, Poland

Allmedica Badania Kliniczne

Nowy Targ, Poland

Centrum medyczne Solumed

Poznan, Poland

View Full Details on ClinicalTrials.gov

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NCT06568627


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