[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MediWound Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100559783","phase-3-a-double-blind-study-performed-to-evaluate-the-efficacy-and-the-safety-of-escharex-in-debridement-of-vlu-value-100559783",false,"NCT06568627","A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)","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)","VALUE","Inclusion Criteria:\n\n1. Men or women, older than 18 years of age,\n2. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),\n3. Wound is present for at least 4 weeks but no longer than 1 year,\n4. The adherent necrotic\u002Fthick slough\u002Ffibrin 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),\n5. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),\n6. 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.\n\nExclusion Criteria:\n\n1. Wound size that has decreased by \\> 20% after 7 (+3\u002F-1) days of the screening period,\n2. 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,\n3. Signs of clinical infection of the wound or peri-wound, including purulent discharge, deep-tissue abscess, erysipelas, cellulitis, etc.,\n4. Severely damaged skin (e.g. abrasion, erosion, exfoliation) extending \\>2 cm around the wound's edge,\n5. Presence of gangrene, signs of systemic infection, sepsis, or osteomyelitis during screening phase,\n6. 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,\n7. Patients with skin disorders unrelated to the wound that are presented adjacent to the wound,\n8. Patients suffering from chronic skin disorders (Idiopathic Pruritus, Psoriasis, Panniculitis, Pyoderma gangrenosum, etc.) that might deteriorate as a result of local trauma or debridement,\n9. Wound has sinus tracts or tunnels extending under healthy tissue or penetrating into periosteum, fascia or bone,\n10. Patients with primary lymphatic edema (Lymphedema),\n11. 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,\n12. 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),\n13. 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,\n14. Patients with poor nutritional status: albumin \\\u003C 2.5 g\u002Fdl; poorly controlled diabetes mellitus (HbA1c \\> 12%); anemia (hemoglobin\\\u003C8 g\u002FdL), leukocyte count \\\u003C 3,000\u002Fμl or \\>15000\u002Fμl; neutrophil count ≤1000\u002Fμl; platelets \\\u003C100,000\u002Fμl, abnormal liver function (AST, ALT\\>2 x upper limit of normal range), renal failure (Cr \\> 2.5 mg\u002Fdl or eGFR \\\u003C 30ml\u002Fmin \u002F1.73m2), BMI\\>48,\n15. 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),\n16. Patients undergoing renal or peritoneal dialysis,\n17. 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,\n18. Recent history or concurrent acute injury or disease that might compromise the patient's welfare, according to investigator discretion,\n19. 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. These include chronic systemic steroid intake5 associated with topical skin changes (i.e. thin, fragile skin with multiple hematomas or a history of laceration), immuno-suppressive 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,\n20. Patients treated with Pentoxifylline within 2 weeks prior to screening,\n21. Venous ablation performed within the past month in an area adjacent to the target wound,\n22. Mentally incapacitated incompetent adults who are incapable of giving legal consent (e.g., dementia, psychiatric patients, etc.),\n23. Concurrent use of non-approved drugs or alcohol abuse,\n24. Pregnant women (positive pregnancy test) or nursing mothers,\n25. 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.","ALL","18 Years",{"count":20,"type":21},216,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The main objective of this study is:\n\nTo 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).",[27],"Venous Leg Ulcer (VLU)",[29,30,31,32],"VLU","EscharEx","Debridement","Wound bed preparation","RECRUITING","2026-03-27",{"date":36,"type":37},"2026-04-02","ACTUAL",{"date":39,"type":37},"2025-06-01",{"date":41,"type":21},"2027-03",{"name":43,"class":44},"MediWound Ltd","INDUSTRY",25,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":29,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100569125","phase-2-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-100569125","NCT06690177","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","A Multicenter, Prospective, Randomized, Placebo and Collagenase (Non-surgical Standard-of-care) Controlled Study, Performed to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase in Patients With Venous Leg Ulcers","Inclusion Criteria:\n\n1. Men or women, older than 18 years of age,\n2. Patients with a VLU (determined by medical history, physical examination, and a documented ultrasound scan demonstrating venous insufficiency),\n3. Wound is present for at least 4 weeks but no longer than 1 year,\n4. The necrotic\u002Fslough\u002Ffibrin non-viable tissue area is at least 50% of the wound area (assessed by clinical evaluation),\n5. Target wound surface area is in the range of 2-25 cm2 (assessed by eKare inSightTM),\n6. 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\n\nExclusion Criteria:\n\n1.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 \\\u003C 2.5g\u002Fdl, poorly controlled diabetes Mellitus (HbA1c \\> 12%), anemia (hemoglobin\\\u003C8 g\u002FdL), a leukocyte counts \\\u003C 3,000\u002Fμl or \\>15000\u002Fμl, neutrophil count ≤1000\u002F μl, platelets \\\u003C100,000\u002Fμl, abnormal liver function (AST, ALT\\>2 x upper limit of normal range), renal failure (Cr \\> 2.5 mg\u002Fdl and eGFR \\\u003C 30ml\u002F min \u002F1.73m2), 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.\n\n\\-",{"count":54,"type":21},45,[56],"PHASE2","The main objective of this study is:\n\nTo assess the safety of EscharEx (EX-03 5% formulation) compared to placebo control and compared to Collagenase (NSSOC) in patients with VLU.",[59],"Venus Leg Ulcers",[29,30,31],"NOT_YET_RECRUITING","2024-11-14",{"date":64,"type":37},"2024-11-15",{"date":66,"type":21},"2025-04-30",{"date":68,"type":21},"2028-09-30",{"name":43,"class":44},2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":5},"100451381","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-escharex-ex-02-in-the-treatment-of-basal-cell-carcinoma-100451381","NCT05157763","A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma","An Open-Label Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma","Inclusion Criteria:\n\nInclusion Criteria- Patient level\n\n1. Male or female greater than age 18,\n2. Patients with one primary superficial or nodular basal cell carcinoma lesion (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy.\n3. Lesion is present for no longer than 4 years.\n4. Lesion with a diameter of 5-10mm,\n5. Patient and\u002For legally authorized representative (LAR) understands the nature of the procedure, is able and willing to adhere to the protocol regimen, and able to provide a written informed consent prior to any study procedure.\n\nExclusion Criteria:\n\nExclusion Criteria- Patient level\n\n1. Evidence of Gorlin syndrome, neoplastic diseases (except actinic lesions), metastatic tumor or tumor with high probability of metastatic spread,\n2. Other malignant cancers (non BCC) of the skin at the lesion's site,\n3. Morphea-type basal cell carcinoma (MBCC) at the lesion's site (per biopsy report),\n4. Any signs of infection at the lesion site including purulent discharge, tissue abscess, erysipelas, cellulitis, etc.,\n5. Patients with any dermatological disease in the target lesion site or surrounding area (not including chronic actinic damage in the surrounding area),\n6. History of allergy or atopic disease or a known sensitivity to pineapples, papaya, bromelain or papain, as well as known sensitivity to latex proteins (known as latex-fruit syndrome), bee venom or olive tree pollen,\n7. Patients undergoing renal or peritoneal dialysis,\n8. Any condition that would preclude safe participation in the study, e.g. evidence of significant or unstable cardiovascular, pulmonary, liver, hematological, immunological, or any immediate life threatening condition,\n9. Concurrent acute injury or disease that might compromise the patient's welfare or the participation in the study,\n10. Current (within last 12 months) severe alcohol or drug use disorder\n11. Pregnant women (positive blood or urine pregnancy test) or nursing mothers,\n12. Exposure to investigational intervention within 4 weeks prior to enrolment, or anticipated participation in another investigational drug trial or other intervention trial, while enrolled in the study.",{"count":79,"type":21},32,[81,56],"PHASE1","This study will be a multicenter, prospective, open label, one-arm study intended to assess the Safety and Efficacy of EscharEx (EX-02) in the treatment of Basal Cell Carcinoma.\n\nIn patients with one primary superficial or nodular basal cell carcinoma lesion with a diameter of 5-10mm (Histologically confirmed BCC) located on the trunk or upper extremities (not including the hands), with well-defined borders and no previous radiation therapy.",[84,85],"Superficial Basal Cell Carcinoma","Nodular Basal Cell Carcinoma","2021-12-01",{"date":88,"type":37},"2021-12-15",{"date":90,"type":37},"2021-06-30",{"date":92,"type":21},"2022-06",{"name":43,"class":44},""]