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

NCT06568627 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: MW2022-06-22
• Study Type: interventional
• Target: 216
• Locations: 5 countries
• Sites: 25

Brief 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).

Conditions

Venous Leg Ulcer (VLU)

Keywords

VLU; EscharEx; Debridement; Wound bed preparation

Outcome Measures

Primary Outcomes (2)

• Incidence of complete debridement, clinically (visually) assessed after each application

  counting events of complete debridement

  up to 2 weeks

• Facilitation of wound closure, clinically assessed, as measured by time to complete wound closure

  counting events of complete wound closure until completion of weekly visits

  up to 12 weeks

Secondary Outcomes (4)

• Incidence of complete healthy viable granulation tissue, as assessed clinically

  up to 2 weeks

• Time to the first declaration of complete debridement, clinically assessed

  up to 12 weeks

• Time to Wound Bed Prepared, clinically assessed

  up to 12 weeks

• Incidence of complete wound closure, clinically assessed,

  up to 12 weeks

Other Outcomes (5)

• Incidence and severity of systemic and local adverse events

  up to 27 weeks

• Incidence of target wound infections

  up to 27 weeks

• Incidence of discontinuation due to adverse events

  up to 27 weeks

Study Arms (2)

EscharEx (EX-03)

ACTIVE COMPARATOR

EX-03 is the code name of the third generation of EscharEx investigational medicinal product (IMP) formulation. A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is blended with excipients. EX-03 5% powder, should be diluted with Water for Injection (WFI) prior usage.

Drug: EscharEx (EX-03)

Placebo

PLACEBO COMPARATOR

Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API. Placebo powder, should be diluted with Water for Injection (WFI) prior usage.

Drug: Placebo (Gel vehicle)

Interventions

EscharEx (EX-03) DRUG

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.

Also known as: EX-03

EscharEx (EX-03)

Placebo (Gel vehicle) DRUG

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

Also known as: Gel vehicle

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women, older than 18 years of age,
• Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),
• Wound is present for at least 4 weeks but no longer than 1 year,
• The adherent necrotic/thick slough/fibrin non-viable tissue area, assessed following wound cleansing with wet gauze and either sterile saline or water and mild soap, at least 50% of the wound area (assessed by clinical evaluation),
• Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),
• Patient understands the nature of the procedure, is able to adhere to the protocol regimen, and provides a written informed consent prior to any study procedure.

You may not qualify if:

• Wound size that has decreased by \> 20% after 7 (+3/-1) days of the screening period,
• Patients with more than one leg ulcer, on the leg of the target wound, with an area greater than or equal to 2 cm2, that are between 2cm and 5cm away from the edge of the target wound,
• Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,
• Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending \>2 cm around the wound's edge,
• Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,
• Clinical suspicion of skin cancer (e.g., basal cell carcinoma (BCC), squamous cell carcinoma (SCC), melanoma, or sarcoma), near the target wound, which was not ruled out by biopsy,
• Patients with skin disorders unrelated to the wound that are presented adjacent to the wound,
• Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,
• Wound has sinus tracts or tunnels extending under healthy tissue or penetrating into periosteum, fascia or bone,
• Patients with primary lymphatic edema (Lymphedema),
• A significant decrease in the arterial blood flow of the extremity, as demonstrated by either Toe-Brachial Index (TBI) ≤ 0.50, Ankle-Brachial Index (ABI) ≤ 0.70, Skin Perfusion Pressure (SPP) ≤ 40 mmHg, Transcutaneous oximetry (TCOM) ≤ 40 mmHg, or lack of bi-phasic or tri-phasic doppler wave forms,
• Patients with pre-enrollment wounds which are covered by eschar heavily saturated with iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e., pseudoeschar as a result of SSD treatment),
• History of allergy or atopic disease or a known sensitivity to pineapples, bromelain, papaya or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,
• Patients with poor nutritional status: albumin \< 2.5 g/dl; poorly controlled diabetes mellitus (HbA1c \> 12%); anemia (hemoglobin\<8 g/dL), leukocyte count \< 3,000/μl or \>15000/μl; neutrophil count ≤1000/μl; platelets \<100,000/μl, abnormal liver function (AST, ALT\>2 x upper limit of normal range), renal failure (Cr \> 2.5 mg/dl or eGFR \< 30ml/min /1.73m2), BMI\>48,
• INR\>2 or PTT \> x 2 ULN (unless the patient receives coumarin derivatives anticoagulants (e.g. warfarin), and the INR and PTT levels are in their required levels and are stable),

Sponsors & Collaborators

• MediWound Ltd: lead

Study Sites (25)

Limb Preservation Platform, Inc

Fresno, California, 93710, United States

NOT YET RECRUITING

Angel City Research,Inc

Los Angeles, California, 90010, United States

RECRUITING

Center for Clinical Research INC

San Francisco, California, 94115, United States

RECRUITING

ILD Research Center

Vista, California, 92081, United States

NOT YET RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

NOT YET RECRUITING

Rutgers New Jersey Medical Center

Newark, New Jersey, 07103, United States

RECRUITING

Northwell Health Comprehensive Wound Healing Center

Lake Success, New York, 11042, United States

ACTIVE NOT RECRUITING

NYU Langone Health Long Island - Research & Academic Center

Mineola, New York, 11501, United States

RECRUITING

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

Cutting Edge Research LLC.,

Circleville, Ohio, 43113, United States

RECRUITING

Clinical Trial Network Houston

Houston, Texas, 77074, United States

RECRUITING

Woundcentrics, LLC

San Antonio, Texas, 78251, United States

NOT YET RECRUITING

Medical University of Graz

Graz, 8036, Austria

RECRUITING

Medical University Wien

Vienna, 1090, Austria

RECRUITING

Ruhr-University Bochum

Bochum, Germany

RECRUITING

Städtisches Klinikum Dresden

Dresden, Germany

RECRUITING

Wundzentrum Dermatologie Erlangen

Erlangen, Germany

RECRUITING

DermaKiel - Allergie und Haut Centrum

Kiel, Germany

RECRUITING

Asaf Harofeh (Shamir) Medical Center

Be’er Ya‘aqov, Israel

RECRUITING

Kaplan Medical Center

Rehovot, Israel

RECRUITING

MIKOMED Sp. z o.o.

Lodz, Poland

RECRUITING

Allmedica Badania Kliniczne

Nowy Targ, Poland

RECRUITING

Centrum medyczne Solumed

Poznan, Poland

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Gels

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Yael Katz-levy, Ph.D.

CONTACT

+972-546774149; yaelk@mediwound.com

Aya Ben-Yaakov, Ph.D

CONTACT

+972-508814005; ayab@mediwound.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, prospective, randomized, double blind, placebo controlled, adaptive design study.

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 23, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); DE (4); IL (2); AU (2); US (14)