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Tests treatment safety and results for Venous Leg Ulcer (VLU)
Official title A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
ClinicalTrials.gov ID: NCT06568627
What this study is testing
What is EscharEx (EX-03)?
EscharEx (EX-03) is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for venous leg ulcer (vlu).
Also referred to as EX-03.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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 \ 12%); anemia (hemoglobin\ 15000/μl; neutrophil count ≤1000/μl; platelets \ 2 x upper limit of normal range), renal failure (Cr \> 2.5 mg/dl or eGFR \ 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...
- Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion,
- The patient is currently receiving, has received within three months prior to enrollment, or is planned to receive during trial period, any medications or treatments at doses known to impair the wound healing processes...
- Patients treated with Pentoxifylline within 2 weeks prior to screening,
- Venous ablation performed within the past month in an area adjacent to the target wound,
- Mentally incapacitated 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fresno, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Vista, California, United States
- Miami, Florida, United States
- Boston, Massachusetts, United States
- Newark, New Jersey, United States
- Lake Success, New York, United States
- Mineola, New York, United States
- New York, New York, United States
- Circleville, Ohio, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Graz, Austria
- Vienna, Austria
- Bochum, Germany
- Dresden, Germany
- Erlangen, Germany
- Kiel, Germany
- Be’er Ya‘aqov, Israel
+ 4 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fresno, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Vista, California, United States; Miami, Florida, United States; Boston, Massachusetts, United States and 18 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.