RECRUITING

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

Conditions

Venous Leg Ulcer (VLU)VLU EscharEx Debridement Wound bed preparation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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)

Quick Facts

Study Start:2025-04

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06568627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Men or women, older than 18 years of age, 2. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency), 3. Wound is present for at least 4 weeks but no longer than 1 year, 4. The necrotic/slough/fibrin non-viable tissue area is at least 50% of the wound area (assessed by clinical evaluation), 5. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM), 6. 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.	1. Wound size decreased by \> 20% after 1 week of standard-of-care-only period (screening period), 2. Patients with more than one leg ulcer , on the leg of the target wound, with an area greater than or equal to 2 cm2, 3. Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc., 4. Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending \>2 cm around the wound's edge, 5. Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase, 6. 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, 7. Patients with skin disorders unrelated to the wound that are presented adjacent to the wound, 8. Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement, 9. Wound has sinus tracts or tunnels extending under healthy tissue or penetrating into periosteum, fascia or bone, 10. Patients with primary lymphatic edema (Lymphedema), 11. A significant decrease in the arterial blood flow of the extremity , 12. Known small vessels disease (PVD) of any etiology, 13. Patients with pre-enrolment 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), 14. 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, 15. Patients with poor nutritional status: albumin \< 2.5g/dl, poorly controlled diabetes Mellitus (HbA1c \> 12%), anemia (hemoglobin\<8 g/dL), a leukocyte counts \< 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 and eGFR \< 30ml/ min /1.73m2), BMI\>48, 16. 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), 17. Patients undergoing renal or peritoneal dialysis, 18. Any condition that would preclude safe participation in the study, e.g. significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, neoplastic disease, active COVID-19, or any immediate life threatening condition, 19. Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion, 20. Patient is currently receiving, or has received at any time within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments known to affect the wound healing processes; these include chronic systemic steroid intake with topical skin changes (i.e. thin, fragile skin with multiple heamatomas or previous laceration history) immuno-suppressive drugs, immunomodulating medications, chemotherapy and radiation therapy, 21. In case the subject is treated with Pentoxifylline, dosing is stable less than 4 weeks, 22. Mentally incompetent adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc.), 23. Concurrent use of non-approved drugs or alcohol abuse, 24. Pregnant women (positive pregnancy test) or nursing mothers, 25. Exposure to investigational intervention within three months prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.

Inclusion Criteria

Exclusion Criteria

1. Men or women, older than 18 years of age,
2. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),
3. Wound is present for at least 4 weeks but no longer than 1 year,
4. The necrotic/slough/fibrin non-viable tissue area is at least 50% of the wound area (assessed by clinical evaluation),
5. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),
6. 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.

1. Wound size decreased by \> 20% after 1 week of standard-of-care-only period (screening period),
2. Patients with more than one leg ulcer , on the leg of the target wound, with an area greater than or equal to 2 cm2,
3. Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,
4. Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending \>2 cm around the wound's edge,
5. Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,
6. 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,
7. Patients with skin disorders unrelated to the wound that are presented adjacent to the wound,
8. Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,
9. Wound has sinus tracts or tunnels extending under healthy tissue or penetrating into periosteum, fascia or bone,
10. Patients with primary lymphatic edema (Lymphedema),
11. A significant decrease in the arterial blood flow of the extremity ,
12. Known small vessels disease (PVD) of any etiology,
13. Patients with pre-enrolment 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),
14. 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,
15. Patients with poor nutritional status: albumin \< 2.5g/dl, poorly controlled diabetes Mellitus (HbA1c \> 12%), anemia (hemoglobin\<8 g/dL), a leukocyte counts \< 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 and eGFR \< 30ml/ min /1.73m2), BMI\>48,
16. 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),
17. Patients undergoing renal or peritoneal dialysis,
18. Any condition that would preclude safe participation in the study, e.g. significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, neoplastic disease, active COVID-19, or any immediate life threatening condition,
19. Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion,
20. Patient is currently receiving, or has received at any time within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments known to affect the wound healing processes; these include chronic systemic steroid intake with topical skin changes (i.e. thin, fragile skin with multiple heamatomas or previous laceration history) immuno-suppressive drugs, immunomodulating medications, chemotherapy and radiation therapy,
21. In case the subject is treated with Pentoxifylline, dosing is stable less than 4 weeks,
22. Mentally incompetent adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc.),
23. Concurrent use of non-approved drugs or alcohol abuse,
24. Pregnant women (positive pregnancy test) or nursing mothers,
25. Exposure to investigational intervention within three months prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.

Contacts and Locations

Study Contact

Yael Katz-levy, Ph.D.

CONTACT

+972-546774149

yaelk@mediwound.com

Keren David-Zarbiv, M.Sc.

CONTACT

+972-542233052

kerend@mediwound.com

Study Locations (Sites)

Limb Preservation Platform, Inc

Fresno, California, 93710

United States

Center for Clinical Research INC

San Francisco, California, 94115

United States

Northwell Health Comprehensive Wound Healing Center

Lake Success, New York, 11042

United States

JPS Health Network/Acclaim Multispecialty Clinic

Fort Worth, Texas, 76104

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: MediWound Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-04

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

VLU
EscharEx
Debridement
Wound bed preparation

Additional Relevant MeSH Terms

Venous Leg Ulcer (VLU)