Actively Recruiting
A Multicenter, Prospective, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of EscharEx in Debridement of Venous Leg Ulcers
Led by MediWound Ltd · Updated on 2026-04-02
216
Participants Needed
25
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the use of EscharEx, a proteolytic enzyme gel, compared to a placebo gel in treating venous leg ulcers (VLU) in adults. The goal is to evaluate how well EscharEx works and how safe it is for removing dead tissue (debridement) and preparing the wound bed for healing. This study involves adult patients who have VLUs with specific size and duration criteria. Participants will be randomly assigned to receive either EscharEx (EX-03 5% formulation) or a placebo gel. The treatment involves applying a gel made by mixing a sterile powder with water to the wound area. The study lasts up to 29 weeks and includes several phases: a screening period, up to 8 daily visits for debridement within 2 weeks, weekly wound management visits for up to 12 weeks including wound closure confirmation, and monthly visits over 12 weeks to monitor wound closure durability. During the study, patients will undergo regular clinical assessments of the wound, including visual checks for complete debridement and wound closure, as well as evaluations of healthy tissue growth. The study measures the time taken for complete wound closure and the presence of healthy tissue. Safety and wound healing progress are closely monitored throughout the treatment and follow-up periods, ensuring adherence to the protocol and proper wound management.
CONDITIONS
Brief Title
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women older than 18 years of age
- Diagnosis of venous leg ulcer confirmed by medical history, physical exam, and ultrasound
- Wound duration between 4 weeks and 1 year
- Necrotic or non-viable tissue covers at least 50% of the wound area after cleansing
- Wound size between 2 and 25 square centimeters
- Ability to understand the procedure, adhere to the study protocol, and provide written informed consent
You will not qualify if you...
- Wound size that decreases by more than 20% during screening period
- More than one leg ulcer near the target wound larger than or equal to 2 cm2 and close to the target wound
- Signs of wound or surrounding skin infection
- Severely damaged skin extending more than 2 cm around the wound
- Presence of gangrene, systemic infection, sepsis, or osteomyelitis
- Suspicion of skin cancer near the wound not ruled out by biopsy
- Skin disorders unrelated to the wound adjacent to the wound
- Chronic skin disorders that may worsen by trauma or debridement
- Wounds with sinus tracts or tunnels under healthy tissue or into bone
- Primary lymphatic edema
- Significant arterial blood flow decrease in the affected limb
- Wounds covered by iodine-saturated eschar or silver sulfadiazine pseudoeschar
- Allergies to pineapple, bromelain, papaya, papain, latex proteins, bee venom, or olive tree pollen
- Poor nutritional status or uncontrolled diabetes
- Abnormal blood counts or liver and kidney function
- High INR or PTT levels unless stable on anticoagulants
- Receiving dialysis
- Conditions precluding safe participation such as severe cardiac, vascular, pulmonary, liver, hematological, immune, neoplastic diseases, or active COVID-19
- Recent acute injuries or diseases affecting welfare
- Use of medications impairing wound healing within 3 months prior or planned during trial
- Use of Pentoxifylline within 2 weeks before screening
- Venous ablation within past month near the wound
- Mentally incapacitated adults unable to consent
- Use of non-approved drugs or alcohol abuse
- Pregnant or nursing women
- Participation in other investigational trials within 1 month prior or planned concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
2 visits, 7 days apart
Duration - Up to 2 weeks
Participants receive daily debridement treatment with the investigational product or placebo applied to the wound area.
Up to 8 daily site visits within up to 2 weeks
Duration - Up to 12 weeks
Participants undergo weekly wound management to monitor and support wound healing.
Up to 13 weekly visits plus optional wound closure confirmation visits up to 2 weeks
Duration - 12 weeks
Participants have monthly visits to assess the durability of wound closure after treatment completion.
3 visits within 12 weeks
Trial Site Locations
Total: 25 locations
1
Limb Preservation Platform, Inc
Fresno, California, United States, 93710
Not Yet Recruiting
2
Angel City Research,Inc
Los Angeles, California, United States, 90010
Actively Recruiting
3
Center for Clinical Research INC
San Francisco, California, United States, 94115
Actively Recruiting
4
ILD Research Center
Vista, California, United States, 92081
Not Yet Recruiting
5
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Boston Medical Center
Boston, Massachusetts, United States, 02118
Not Yet Recruiting
8
Rutgers New Jersey Medical Center
Newark, New Jersey, United States, 07103
Actively Recruiting
9
Northwell Health Comprehensive Wound Healing Center
Lake Success, New York, United States, 11042
Active, Not Recruiting
10
NYU Langone Health Long Island - Research & Academic Center
Mineola, New York, United States, 11501
Actively Recruiting
11
Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
12
Cutting Edge Research LLC.,
Circleville, Ohio, United States, 43113
Actively Recruiting
13
Clinical Trial Network Houston
Houston, Texas, United States, 77074
Actively Recruiting
14
Woundcentrics, LLC
San Antonio, Texas, United States, 78251
Not Yet Recruiting
15
Medical University of Graz
Graz, Austria, 8036
Actively Recruiting
16
Medical University Wien
Vienna, Austria, 1090
Actively Recruiting
17
Ruhr-University Bochum
Bochum, Germany
Actively Recruiting
18
Städtisches Klinikum Dresden
Dresden, Germany
Actively Recruiting
19
Wundzentrum Dermatologie Erlangen
Erlangen, Germany
Actively Recruiting
20
DermaKiel - Allergie und Haut Centrum
Kiel, Germany
Actively Recruiting
21
Asaf Harofeh (Shamir) Medical Center
Be’er Ya‘aqov, Israel
Actively Recruiting
22
Kaplan Medical Center
Rehovot, Israel
Actively Recruiting
23
MIKOMED Sp. z o.o.
Lodz, Poland
Actively Recruiting
24
Allmedica Badania Kliniczne
Nowy Targ, Poland
Actively Recruiting
25
Centrum medyczne Solumed
Poznan, Poland
Actively Recruiting
Research Team
Y
Yael Katz-levy, Ph.D.
A
Aya Ben-Yaakov, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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