A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
- Conditions
- Venous Leg Ulcer (VLU)
- Registration Number
- NCT06568627
- Lead Sponsor
- MediWound Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 216
Inclusion Criteria:<br><br> 1. Men or women, older than 18 years of age,<br><br> 2. Patients with a VLU (determined by medical history, physical examination, and a<br> documented ultrasound scan demonstrating venous insufficiency),<br><br> 3. Wound is present for at least 4 weeks but no longer than 1 year,<br><br> 4. The necrotic/slough/fibrin non-viable tissue area is at least 50% of the wound area<br> (assessed by clinical evaluation),<br><br> 5. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),<br><br> 6. Patient understands the nature of the procedure, is able to adhere to the protocol<br> regimen, and provides a written informed consent prior to any study procedure.<br><br>Exclusion Criteria:<br><br> 1. Wound size decreased by > 20% after 1 week of standard-of-care-only period<br> (screening period),<br><br> 2. Patients with more than one leg ulcer , on the leg of the target wound, with an area<br> greater than or equal to 2 cm2,<br><br> 3. Signs of clinical infection of the wound or peri-wound, including purulent<br> discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,<br><br> 4. Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending >2 cm around<br> the wound's edge,<br><br> 5. Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during<br> screening phase,<br><br> 6. Clinical suspicion of skin cancer (e.g., basal cell carcinoma (BCC), squamous cell<br> carcinoma (SCC), melanoma, or sarcoma), near the target wound, which was not ruled<br> out by biopsy,<br><br> 7. Patients with skin disorders unrelated to the wound that are presented adjacent to<br> the wound,<br><br> 8. Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis,<br> Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of<br> local trauma or debridement,<br><br> 9. Wound has sinus tracts or tunnels extending under healthy tissue or penetrating into<br> periosteum, fascia or bone,<br><br> 10. Patients with primary lymphatic edema (Lymphedema),<br><br> 11. A significant decrease in the arterial blood flow of the extremity ,<br><br> 12. Known small vessels disease (PVD) of any etiology,<br><br> 13. Patients with pre-enrolment wounds which are covered by eschar heavily saturated<br> with iodine or by silver sulfadiazine (SSD) pseudoeschar (i.e. pseudoeschar as a<br> result of SSD treatment),<br><br> 14. History of allergy or atopic disease or a known sensitivity to pineapples,<br> bromelain, papaya or papain, as well as known sensitivity to latex proteins (known<br> as latex-fruit syndrome), bee venom or olive tree pollen,<br><br> 15. Patients with poor nutritional status: albumin < 2.5g/dl, poorly controlled diabetes<br> Mellitus (HbA1c > 12%), anemia (hemoglobin<8 g/dL), a leukocyte counts < 3,000/µl or<br> >15000/µl, neutrophil count =1000/ µl, platelets <100,000/µl, abnormal liver<br> function (AST, ALT>2 x upper limit of normal range), renal failure (Cr > 2.5 mg/dl<br> and eGFR < 30ml/ min /1.73m2), BMI>48,<br><br> 16. INR>2 or PTT > x 2 ULN (unless the patient receives coumarin derivatives<br> anticoagulants (e.g. warfarin), and the INR and PTT levels are in their required<br> levels and are stable),<br><br> 17. Patients undergoing renal or peritoneal dialysis,<br><br> 18. Any condition that would preclude safe participation in the study, e.g. significant<br> or unstable cardiovascular, pulmonary, liver, hematological, immunological,<br> neoplastic disease, active COVID-19, or any immediate life threatening condition,<br><br> 19. Recent history or concurrent acute injury or disease that might compromise the<br> patient's welfare, according to investigator discretion,<br><br> 20. Patient is currently receiving, or has received at any time within three months<br> prior to enrollment, or is planned to receive during trial period, any medications<br> or treatments known to affect the wound healing processes; these include chronic<br> systemic steroid intake with topical skin changes (i.e. thin, fragile skin with<br> multiple heamatomas or previous laceration history) immuno-suppressive drugs,<br> immunomodulating medications, chemotherapy and radiation therapy,<br><br> 21. In case the subject is treated with Pentoxifylline, dosing is stable less than 4<br> weeks,<br><br> 22. Mentally incompetent adults who are incapable of giving legal consent (e.g.<br> dementia, psychiatric patients, etc.),<br><br> 23. Concurrent use of non-approved drugs or alcohol abuse,<br><br> 24. Pregnant women (positive pregnancy test) or nursing mothers,<br><br> 25. Exposure to investigational intervention within three months prior to enrollment, or<br> anticipated participation in another investigational drug trial or other<br> intervention trial, while enrolled in the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of complete debridement, clinically (visually) assessed after each application;Incidence of complete wound closure
- Secondary Outcome Measures
Name Time Method Incidence of complete healthy viable granulation tissue, as assessed clinically;Time to the first declaration of complete debridement, clinically assessed;Time to complete wound closure, clinically assessed;Percent change in wound area, as assessed by eKare inSightTM