Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers

Launched by MEDIWOUND LTD · Nov 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called EscharEx (EX-03 formulation) to see if it is safe and effective for treating venous leg ulcers (VLUs). VLUs are painful sores that can occur on the legs due to poor blood flow. The trial will compare EscharEx to a placebo (which looks like the medication but has no active ingredients) and collagenase, a standard non-surgical treatment. The main goal is to determine how well EscharEx works in promoting healing and whether it has any side effects.

To participate in the trial, individuals must be 18 years or older and have a VLU that has been present for at least four weeks but no longer than one year. The wound should have a significant amount of non-viable tissue, and its size must fall within a specific range. Some people may not be eligible, such as those with certain infections, skin conditions, or other serious health issues. Participants will be monitored throughout the study, and they will need to provide informed consent, meaning they understand the trial and agree to take part. This trial is currently not recruiting participants, but it aims to help improve treatment options for those suffering from VLUs.

Gender

ALL

Eligibility criteria

• Inclusion 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 procedur
• Exclusion Criteria:
• • 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, 6.Patients with skin disorders unrelated to the wound that are presented adjacent to the wound, 7.Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, 8. 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.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), 13.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, 14.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, 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), 15.Patients undergoing renal or peritoneal dialysis, 16.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, 17.Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion, 18.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, In case the subject is treated with Pentoxifylline, dosing is stable less than 4 weeks, 19.Mentally incompetent adults who are incapable of giving legal consent (e.g. dementia, psychiatric patients, etc.), 20.Concurrent use of non-approved drugs or alcohol abuse, 21.Pregnant women (positive pregnancy test) or nursing mothers, 22.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.
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