Actively Recruiting
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
Led by MediWound Ltd · Updated on 2026-04-02
216
Participants Needed
25
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Patients with a venous leg ulcer confirmed by medical history, physical exam, and ultrasound showing venous insufficiency
- Wound present for at least 4 weeks but no longer than 1 year
- At least 50% of the wound area covered by non-viable tissue after cleansing
- Target wound surface area between 2 and 25 cm2
- Patient understands the procedure, can follow the study plan, and provides written informed consent
You will not qualify if you...
- Wound size decreased by more than 20% during the screening period
- More than one leg ulcer on the leg of the target wound with an area ≥ 2 cm2 and located 2-5 cm away from the target wound
- Signs of clinical infection or peri-wound infection such as purulent discharge, abscess, erysipelas, or cellulitis
- Severely damaged skin extending more than 2 cm around the wound
- Presence of gangrene, systemic infection, sepsis, or osteomyelitis during screening
- Suspicion of skin cancer near the wound not ruled out by biopsy
- Skin disorders unrelated to the wound near the wound area
- Chronic skin disorders that may worsen from trauma or debridement
- Wound with sinus tracts or tunnels under healthy tissue or into bone
- Primary lymphatic edema (lymphedema)
- Significant decrease in arterial blood flow as shown by specified vascular tests
- Wounds covered by iodine-saturated eschar or silver sulfadiazine pseudoeschar
- Allergy or sensitivity to pineapples, bromelain, papaya, papain, latex proteins, bee venom, or olive tree pollen
- Poor nutritional status or uncontrolled diabetes or anemia or abnormal blood counts or liver or kidney failure or BMI over 48
- INR over 2 or PTT more than twice upper limit unless stable on warfarin
- Undergoing renal or peritoneal dialysis
- Conditions preventing safe participation such as unstable heart, lung, liver, blood, immune, cancer, or active COVID-19
- Recent or ongoing acute injury or disease compromising welfare
- Use of medications impairing wound healing recently or planned during trial, including chronic steroids, immunosuppressants, chemotherapy, radiation
- Use of Pentoxifylline within 2 weeks prior to screening
- Venous ablation near target wound within past month
- Mentally incapacitated adults unable to consent
- Concurrent use of non-approved drugs or alcohol abuse
- Pregnant or nursing women
- Participation in another investigational drug or intervention trial within one month prior or during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
A
Aya Ben-Yaakov, Ph.D
CONTACT
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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