[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559783":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":44,"responsibleParty":505,"collaborators":33,"id":507,"slug":508,"hasResults":509,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":509,"sex":515,"minAge":516,"maxAge":33,"enrollmentInfo":517,"targetDuration":33,"studyType":520,"phases":521,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":69,"whyStopped":33,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":540},{"fullName":5,"class":6},"MediWound Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EscharEx (EX-03)","ACTIVE_COMPARATOR","EX-03 is the code name of the third generation of EscharEx investigational medicinal product (IMP) formulation. A sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb ), the active pharmaceutical ingredient (API), that is blended with excipients.\n\nEX-03 5% powder, should be diluted with Water for Injection (WFI) prior usage.",[13],"Drug: EscharEx (EX-03)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo (Gel Vehicle, hydrogel) contains the same excipients as in EX-03, without the API.\n\nPlacebo powder, should be diluted with Water for Injection (WFI) prior usage.",[19],"Drug: Placebo (Gel vehicle)",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","a sterile lyophilized powder containing a concentrate of proteolytic enzymes enriched in bromelain (anacaulase-bcdb). The powder and sterile water are mixed to form a gel prior to application on the wound area.",[9],[26],"EX-03",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo (Gel vehicle)","A sterile powder containing excipients only (no proteolytic enzymes). The powder and sterile water are mixed to form a gel prior to application on the wound area",[15],[32],"Gel vehicle",null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Yael Katz-levy, Ph.D.","CONTACT","+972-546774149","yaelk@mediwound.com",{"name":41,"role":37,"phone":42,"phoneExt":33,"email":43},"Aya Ben-Yaakov, Ph.D","+972-508814005","ayab@mediwound.com",[45,67,88,110,129,149,169,185,206,217,237,259,276,296,316,338,354,371,390,405,423,443,458,475,490],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Limb Preservation Platform, Inc","NOT_YET_RECRUITING","Fresno","California","93710","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-119.77237,36.74773,{"lat":57,"lon":56},[60,64],{"name":61,"role":37,"phone":62,"phoneExt":33,"email":63},"Destiny Blackstone, SC","(800) 714-8011","Destiny@LPPresearch.com",{"name":65,"role":66,"phone":33,"phoneExt":33,"email":33},"Shawn Cazzell, DPM","PRINCIPAL_INVESTIGATOR",{"facility":68,"status":69,"city":70,"state":49,"zip":71,"country":51,"countryCode":52,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Angel City Research,Inc","RECRUITING","Los Angeles","90010",{"type":54,"coordinates":73},[74,75],-118.24368,34.05223,{"lat":75,"lon":74},[78,82,86],{"name":79,"role":37,"phone":80,"phoneExt":33,"email":81},"Maira Jackson, SC","213-631-0596","maira@angelcityresearch.com",{"name":83,"role":37,"phone":84,"phoneExt":33,"email":85},"Joanna Cuevas, SC","213-365-0793","joanna@angelcityresearch.com",{"name":87,"role":66,"phone":33,"phoneExt":33,"email":33},"Felix Sigal, MD",{"facility":89,"status":69,"city":90,"state":49,"zip":91,"country":51,"countryCode":52,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Center for Clinical Research INC","San Francisco","94115",{"type":54,"coordinates":93},[94,95],-122.41942,37.77493,{"lat":95,"lon":94},[98,102,105,107],{"name":99,"role":37,"phone":100,"phoneExt":33,"email":101},"Maria Peralta, SC","(800) 363-1069","maria@ccr-trials.com",{"name":103,"role":37,"phone":100,"phoneExt":33,"email":104},"Gayana Sarkisova, SC","gayana@ccr-trials.com",{"name":106,"role":66,"phone":33,"phoneExt":33,"email":33},"Alexander Reyzelman, DPM",{"name":108,"role":109,"phone":33,"phoneExt":33,"email":33},"Mher Vartivarian, DPM","SUB_INVESTIGATOR",{"facility":111,"status":47,"city":112,"state":49,"zip":113,"country":51,"countryCode":52,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"ILD Research Center","Vista","92081",{"type":54,"coordinates":115},[116,117],-117.24254,33.20004,{"lat":117,"lon":116},[120,124,127],{"name":121,"role":37,"phone":122,"phoneExt":33,"email":123},"Eric Martinez, SC","760-350-5080","eric@ildresearch.com",{"name":125,"role":37,"phone":122,"phoneExt":33,"email":126},"Yani Manaznares, SC","yani@ildresearch.com",{"name":128,"role":66,"phone":33,"phoneExt":33,"email":33},"Dean Dean Vayser, MD",{"facility":130,"status":69,"city":131,"state":132,"zip":133,"country":51,"countryCode":52,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"University of Miami","Miami","Florida","33136",{"type":54,"coordinates":135},[136,137],-80.19366,25.77427,{"lat":137,"lon":136},[140,144,147],{"name":141,"role":37,"phone":142,"phoneExt":33,"email":143},"Aliette Espinosa, SC","305-689-3376","a.espinosa2@med.miami.edu",{"name":145,"role":37,"phone":142,"phoneExt":33,"email":146},"Leonela Espinoza, SC","Lte17@med.miami.edu",{"name":148,"role":66,"phone":33,"phoneExt":33,"email":33},"Robert Kirsner, MD",{"facility":150,"status":69,"city":151,"state":152,"zip":153,"country":51,"countryCode":52,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":54,"coordinates":155},[156,157],-71.05977,42.35843,{"lat":157,"lon":156},[160,164,167],{"name":161,"role":37,"phone":162,"phoneExt":33,"email":163},"Matthew Supple, SC","617-726-3712","MDSUPPLE@mgh.harvard.edu",{"name":165,"role":37,"phone":162,"phoneExt":33,"email":166},"Daniela Requena, SC","drequena@mgh.harvard.edu",{"name":168,"role":66,"phone":33,"phoneExt":33,"email":33},"Jeremy Goverman, MD",{"facility":170,"status":47,"city":151,"state":152,"zip":171,"country":51,"countryCode":52,"cosmosGeoPoint":172,"geoPoint":174,"contacts":175},"Boston Medical Center","02118",{"type":54,"coordinates":173},[156,157],{"lat":157,"lon":156},[176,180,183],{"name":177,"role":37,"phone":178,"phoneExt":33,"email":179},"Pedro Jardim, SC","617-414-8092","pedro.jardim@bmc.org",{"name":181,"role":37,"phone":178,"phoneExt":33,"email":182},"Emily Meng, SC","emily.meng@bmc.org",{"name":184,"role":66,"phone":33,"phoneExt":33,"email":33},"Elizabeth Sanders, MD",{"facility":186,"status":69,"city":187,"state":188,"zip":189,"country":51,"countryCode":52,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Rutgers New Jersey Medical Center","Newark","New Jersey","07103",{"type":54,"coordinates":191},[192,193],-74.17237,40.73566,{"lat":193,"lon":192},[196,200,204],{"name":197,"role":37,"phone":198,"phoneExt":33,"email":199},"Saharsh Patel, SC","973-972-3173","ssp186@gsbs.rutgers.edu",{"name":201,"role":37,"phone":202,"phoneExt":33,"email":203},"Mehreen Bhatti, SC","(973) 972-5435","mb2276@njms.rutgers.edu",{"name":205,"role":66,"phone":33,"phoneExt":33,"email":33},"Alex Wong, MD",{"facility":207,"status":208,"city":209,"state":210,"zip":211,"country":51,"countryCode":52,"cosmosGeoPoint":212,"geoPoint":216,"contacts":33},"Northwell Health Comprehensive Wound Healing Center","ACTIVE_NOT_RECRUITING","Lake Success","New York","11042",{"type":54,"coordinates":213},[214,215],-73.71763,40.77066,{"lat":215,"lon":214},{"facility":218,"status":69,"city":219,"state":210,"zip":220,"country":51,"countryCode":52,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"NYU Langone Health Long Island - Research & Academic Center","Mineola","11501",{"type":54,"coordinates":222},[223,224],-73.64068,40.74927,{"lat":224,"lon":223},[227,231,235],{"name":228,"role":37,"phone":229,"phoneExt":33,"email":230},"Monica Benitez, SC","516-969-6120","monica.benitez@nyulangone.org",{"name":232,"role":37,"phone":233,"phoneExt":33,"email":234},"Anita Farhi, SC","516-663-9582","anita.farhi@nyulangone.org",{"name":236,"role":66,"phone":33,"phoneExt":33,"email":33},"Scott Gorenstein, MD",{"facility":238,"status":69,"city":210,"state":210,"zip":239,"country":51,"countryCode":52,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Mount Sinai West","10019",{"type":54,"coordinates":241},[242,243],-74.00597,40.71427,{"lat":243,"lon":242},[246,250,253,255,257],{"name":247,"role":37,"phone":248,"phoneExt":33,"email":249},"Tianyi Yang, SC","212-523-8195","Tianyi.Yang@mountsinai.org",{"name":251,"role":37,"phone":248,"phoneExt":33,"email":252},"Garismar Ramirez, SC","garismar.ramirez@mountsinai.org",{"name":254,"role":66,"phone":33,"phoneExt":33,"email":33},"Michael Michael Dudkiewicz, MD",{"name":256,"role":109,"phone":33,"phoneExt":33,"email":33},"John Lantis, MD",{"name":258,"role":109,"phone":33,"phoneExt":33,"email":33},"Mary Bridge, MD",{"facility":260,"status":69,"city":261,"state":262,"zip":263,"country":51,"countryCode":52,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"Cutting Edge Research LLC.,","Circleville","Ohio","43113",{"type":54,"coordinates":265},[266,267],-82.94601,39.60062,{"lat":267,"lon":266},[270,274],{"name":271,"role":37,"phone":272,"phoneExt":33,"email":273},"Marie Liden","614-519-7845","researchbase969@gmail.com",{"name":275,"role":66,"phone":33,"phoneExt":33,"email":33},"Brock Liden, MD",{"facility":277,"status":69,"city":278,"state":279,"zip":280,"country":51,"countryCode":52,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Clinical Trial Network Houston","Houston","Texas","77074",{"type":54,"coordinates":282},[283,284],-95.36327,29.76328,{"lat":284,"lon":283},[287,291,294],{"name":288,"role":37,"phone":289,"phoneExt":33,"email":290},"Shafae Saleem, SC","713-484-6947","SSaleem@CTNtexas.com",{"name":292,"role":37,"phone":289,"phoneExt":33,"email":293},"David Coreas, SC","dcoreas@ctntexas.com",{"name":295,"role":66,"phone":33,"phoneExt":33,"email":33},"Ullabritt Larka, MD",{"facility":297,"status":47,"city":298,"state":279,"zip":299,"country":51,"countryCode":52,"cosmosGeoPoint":300,"geoPoint":304,"contacts":305},"Woundcentrics, LLC","San Antonio","78251",{"type":54,"coordinates":301},[302,303],-98.49363,29.42412,{"lat":303,"lon":302},[306,310,314],{"name":307,"role":37,"phone":308,"phoneExt":33,"email":309},"Tarek Ibrahim, SC","210-703-8454","tarek.ibrahim@woundcentrics.com",{"name":311,"role":37,"phone":312,"phoneExt":33,"email":313},"Jhemima Rizalde, SC","702-427-4653","jhemima.rizalde@woundcentrics.com",{"name":315,"role":66,"phone":33,"phoneExt":33,"email":33},"Marcus Gitterle, MD",{"facility":317,"status":69,"city":318,"state":33,"zip":319,"country":320,"countryCode":321,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"Medical University of Graz","Graz","8036","Austria","AT",{"type":54,"coordinates":323},[324,325],15.44197,47.06733,{"lat":325,"lon":324},[328,332,336],{"name":329,"role":37,"phone":330,"phoneExt":33,"email":331},"Birgit Michelitsch, SC","+43 316 385 31957","birgit.michelitsch@medunigraz.at",{"name":333,"role":37,"phone":334,"phoneExt":33,"email":335},"Ana Villa Garcia, SC","+43 6763406026","ana.villa-garcia@medunigraz.at",{"name":337,"role":66,"phone":33,"phoneExt":33,"email":33},"Lars-Peter Kamolz, MD",{"facility":339,"status":69,"city":340,"state":33,"zip":341,"country":320,"countryCode":321,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"Medical University Wien","Vienna","1090",{"type":54,"coordinates":343},[344,345],16.37208,48.20849,{"lat":345,"lon":344},[348,352],{"name":349,"role":37,"phone":350,"phoneExt":33,"email":351},"Anna Fast, MD","+43 1 40400 69860","anna.fast@meduniwien.ac.at",{"name":353,"role":66,"phone":33,"phoneExt":33,"email":33},"Christine Christine Radtke, MD",{"facility":355,"status":69,"city":356,"state":33,"zip":33,"country":357,"countryCode":358,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"Ruhr-University Bochum","Bochum","Germany","DE",{"type":54,"coordinates":360},[361,362],7.21648,51.48165,{"lat":362,"lon":361},[365,369],{"name":366,"role":37,"phone":367,"phoneExt":33,"email":368},"Maren Hoffmann, SC","+49 234 8792 377","maren.hoffmann@kklbo.de",{"name":370,"role":66,"phone":33,"phoneExt":33,"email":33},"Markus Stücker, MD",{"facility":372,"status":69,"city":373,"state":33,"zip":33,"country":357,"countryCode":358,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"Städtisches Klinikum Dresden","Dresden",{"type":54,"coordinates":375},[376,377],13.73832,51.05089,{"lat":377,"lon":376},[380,384,388],{"name":381,"role":37,"phone":382,"phoneExt":33,"email":383},"Kerstin Spranger, SC","+49 351 480 4553","kerstin.spranger@klinikum-dresden.de",{"name":385,"role":37,"phone":386,"phoneExt":33,"email":387},"Juliane Gehre, SC","+49 351 480 4556","juliane.gehre@klinikum-dresden.de",{"name":389,"role":66,"phone":33,"phoneExt":33,"email":33},"Andre Koch, MD",{"facility":391,"status":69,"city":392,"state":33,"zip":33,"country":357,"countryCode":358,"cosmosGeoPoint":393,"geoPoint":397,"contacts":398},"Wundzentrum Dermatologie Erlangen","Erlangen",{"type":54,"coordinates":394},[395,396],11.00783,49.59099,{"lat":396,"lon":395},[399,403],{"name":400,"role":37,"phone":401,"phoneExt":33,"email":402},"Silke Avignon, SN","+49 0913185-35000","silke.avignon@uk-erlangen.de",{"name":404,"role":66,"phone":33,"phoneExt":33,"email":33},"Cornelia Erfurt-Berge, MD",{"facility":406,"status":69,"city":407,"state":33,"zip":33,"country":357,"countryCode":358,"cosmosGeoPoint":408,"geoPoint":412,"contacts":413},"DermaKiel - Allergie und Haut Centrum","Kiel",{"type":54,"coordinates":409},[410,411],10.13489,54.32133,{"lat":411,"lon":410},[414,418,421],{"name":415,"role":37,"phone":416,"phoneExt":33,"email":417},"Maike de Buhr, SC","+49 431 72972023","Dr.M.de.Buhr@web.de",{"name":419,"role":37,"phone":416,"phoneExt":33,"email":420},"Birgit Johannßon, SC","Stud.birgit.johannsson@gmx.de",{"name":422,"role":66,"phone":33,"phoneExt":33,"email":33},"Harald Brüning, MD",{"facility":424,"status":69,"city":425,"state":33,"zip":33,"country":426,"countryCode":427,"cosmosGeoPoint":428,"geoPoint":432,"contacts":433},"Asaf Harofeh (Shamir) Medical Center","Be’er Ya‘aqov","Israel","IL",{"type":54,"coordinates":429},[430,431],34.83749,31.93864,{"lat":431,"lon":430},[434,438,441],{"name":435,"role":37,"phone":436,"phoneExt":33,"email":437},"Sophia Logvinenko, SC","972-8-9778460","sophial@shamir.gov.il",{"name":439,"role":37,"phone":436,"phoneExt":33,"email":440},"Adam Altmann, SC","Adamal@shamir.gov.il",{"name":442,"role":66,"phone":33,"phoneExt":33,"email":33},"Eyal Shapira, MD",{"facility":444,"status":69,"city":445,"state":33,"zip":33,"country":426,"countryCode":427,"cosmosGeoPoint":446,"geoPoint":450,"contacts":451},"Kaplan Medical Center","Rehovot",{"type":54,"coordinates":447},[448,449],34.81199,31.89421,{"lat":449,"lon":448},[452,456],{"name":453,"role":37,"phone":454,"phoneExt":33,"email":455},"Yael Shaked, SC","972-8-9441106","yaelsha@clalit.org.il",{"name":457,"role":66,"phone":33,"phoneExt":33,"email":33},"Dana Egozi, MD",{"facility":459,"status":69,"city":460,"state":33,"zip":33,"country":461,"countryCode":462,"cosmosGeoPoint":463,"geoPoint":467,"contacts":468},"MIKOMED Sp. z o.o.","Lodz","Poland","PL",{"type":54,"coordinates":464},[465,466],19.47395,51.77058,{"lat":466,"lon":465},[469,473],{"name":470,"role":37,"phone":471,"phoneExt":33,"email":472},"Aleksandra Kwapisz, SC","+48 600919797","mikomed@mikomed.pl",{"name":474,"role":66,"phone":33,"phoneExt":33,"email":33},"Jacek Mikosiński, MD",{"facility":476,"status":69,"city":477,"state":33,"zip":33,"country":461,"countryCode":462,"cosmosGeoPoint":478,"geoPoint":482,"contacts":483},"Allmedica Badania Kliniczne","Nowy Targ",{"type":54,"coordinates":479},[480,481],20.03228,49.47783,{"lat":481,"lon":480},[484,488],{"name":485,"role":37,"phone":486,"phoneExt":33,"email":487},"Marta Spytek, SC","+48 531981164","marta.spytek@allmedica.pl",{"name":489,"role":66,"phone":33,"phoneExt":33,"email":33},"Urszula Brudnik, MD",{"facility":491,"status":69,"city":492,"state":33,"zip":33,"country":461,"countryCode":462,"cosmosGeoPoint":493,"geoPoint":497,"contacts":498},"Centrum medyczne Solumed","Poznan",{"type":54,"coordinates":494},[495,496],16.92993,52.40692,{"lat":496,"lon":495},[499,503],{"name":500,"role":37,"phone":501,"phoneExt":33,"email":502},"Patryk Wlodarczyk, SC","+48 668 864 584","patryk.wlodarczyk@solumed.pl",{"name":504,"role":66,"phone":33,"phoneExt":33,"email":33},"Piotr Zelga, MD",{"type":506,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","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":518,"type":519},216,"ESTIMATED","INTERVENTIONAL",[522],"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).",[525],"Venous Leg Ulcer (VLU)",[527,528,529,530],"VLU","EscharEx","Debridement","Wound bed preparation","2026-03-27",{"date":533,"type":534},"2026-04-02","ACTUAL",{"date":536,"type":534},"2025-06-01",{"date":538,"type":519},"2027-03",{"name":5,"class":6},25]