BridgeMD
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)
EU CTIS ID: 2024-519623-23-00
What this study is testing
To assess the efficacy and safety of 5% EscharEx (EX-03 formulation) compared to placebo, in wound debridement and wound bed preparation of Venous Leg Ulcers (VLU).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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)
- Patients understand 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 likely can't join if
- Wound size that has decreased by > 20% after 7 (+3/-1) days of the screening period
- Recent history or concurrent acute injury or disease that might compromise the patient’s welfare, according to investigator discretion
- The 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 at doses known to affectimpair the wound healing processes; these. These include chronic systemic steroid intake associated with topical skin changes (i.e. thin, fragile skin with multiple hematomas or previous history of laceration), immunosuppressive drugs, immunomodulating medications, chemotherapy, and radiation therapy. Low and intermittent doses that the investigator determines as not clinically significant for wound healing, may be permitted, provided that this determination is based on appropriate clinical judgment and is documented accordingly
- 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
- Patients treated with Pentoxifylline within 2 weeks prior to screening
- Mentally incompetent adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc.)
See the full eligibility criteria
Who can join
- 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)
- Patients understand the nature of the procedure, is able to adhere to the protocol regimen, and provides a written informed consent prior to any study procedure
What rules you out
- Wound size that has decreased by > 20% after 7 (+3/-1) days of the screening period
- Recent history or concurrent acute injury or disease that might compromise the patient’s welfare, according to investigator discretion
- The 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 at doses known to affectimpair the wound healing processes; these. These include chronic systemic steroid intake associated with topical skin changes (i.e. thin, fragile skin with multiple hematomas or previous history of laceration), immunosuppressive drugs, immunomodulating medications, chemotherapy, and radiation therapy. Low and intermittent doses that the investigator determines as not clinically significant for wound healing, may be permitted, provided that this determination is based on appropriate clinical judgment and is documented accordingly
- 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
- Patients treated with Pentoxifylline within 2 weeks prior to screening
- Mentally incompetent adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc.)
- Concurrent use of non-approved drugs or alcohol abuse
- Pregnant women (positive pregnancy test) or nursing mothers
- Exposure to investigational intervention within one month prior to enrollment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study
- 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
- Patients with primary lymphatic edema (Lymphedema)
- 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
- Venous ablation performed within the past month in an area adjacent to the target wound
- 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-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)
- 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 < 2.5g/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 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)
- Patients undergoing renal or peritoneal dialysis
- Any condition that would preclude safe participation in the study, e.g. significant or unstable cardiac, vascular, pulmonary, liver, hematological, immunological, neoplastic disease, active COVID-19, or any immediate life threatening condition
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.