[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561012":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":37,"responsibleParty":185,"collaborators":187,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":11,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":11,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":11,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"VULM s.r.o.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Berovenal®","EXPERIMENTAL",null,[13],"Device: Berovenal®",{"label":15,"type":16,"description":11,"interventionNames":17},"NU-GEL Hydrogel with 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Cukrzycowej","Olsztyn","10-561",{"type":47,"coordinates":143},[144,145],20.49272,53.78376,{"lat":145,"lon":144},[148,152],{"name":149,"role":30,"phone":150,"phoneExt":11,"email":151},"Robert Modzelewski","+48 667517993","robur23@interia.eu",{"name":149,"role":30,"phone":11,"phoneExt":11,"email":11},{"facility":154,"status":40,"city":155,"state":11,"zip":156,"country":78,"countryCode":79,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Centrum Medyczne Omedica Jarosław Opiela I Beata Opiela Spółka Jawna","Poznan","60-111",{"type":47,"coordinates":158},[159,160],16.92993,52.40692,{"lat":160,"lon":159},[163,167],{"name":164,"role":30,"phone":165,"phoneExt":11,"email":166},"Marcelina Kocińska","+48 518345945","marcelina.kocinska@farmepo.com",{"name":168,"role":30,"phone":11,"phoneExt":11,"email":11},"Jarosław Opiela",{"facility":170,"status":40,"city":171,"state":11,"zip":172,"country":78,"countryCode":79,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Ginemedica Sp. z o.o. Sp. k.","Wroclaw","50-414",{"type":47,"coordinates":174},[175,176],17.03006,51.10286,{"lat":176,"lon":175},[179,183],{"name":180,"role":30,"phone":181,"phoneExt":11,"email":182},"Jolanta Cholewa","+48 881334481","j.cholewa@ginemedica.pl",{"name":184,"role":30,"phone":11,"phoneExt":11,"email":11},"Michal Torz",{"type":186,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[188],{"name":189,"class":190},"Premier Research","OTHER","100561012","the-purpose-of-this-study-is-to-assess-clinical-efficacy-and-safety-of-berovenal-intended-to-promote-treatment-and-to-expedite-chronic-diabetic-foot-ulcer-healing-100561012",false,"NCT06584617","The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing","A Prospective, 8-week, Multi-centre, Randomised, Open-label Clinical Investigation Comparing Clinical Efficacy and Safety of Berovenal® with a Reference Amorphous Hydrogel in Subjects with Shallow, Non-infected, Chronic Diabetic Foot Ulcer","Inclusion Criteria:\n\n* male, or female subjects aged 18-85 years;\n* diabetes mellitus (type 1 or 2) documented at least 12 months prior to Visit 1;\n* presence of a diabetic foot ulcer meeting the following criteria (Index ulcer):\n\n  * grade 1 or 2 according to the Wagner classification;\n  * if applicable, surgically debrided ≥ 7 days prior to Visit 1;\n  * at the time of randomisation:\n* sized 1 - 25 cm2;\n* present for ≥ 14 days;\n* offloaded for ≥ 7 days;\n* not infected.\n* HbA1c ≤ 10% (DCCT) or 85.8 mmol\u002Fmol (IFCC) at Visit 1;\n* willing and able to comply with the scheduled procedures;\n* legally capable, able to understand the provided information and willing to sign the informed consent form.\n\nExclusion Criteria:\n\n* known contraindication for application of hydrogel dressings, incl. Berovenal® and NU-GEL Hydrogel with Alginate;\n* at the time of randomisation - documented reduction in Index ulcer area by \\> 20%, as compared to its size at Visit 1;\n* Index ulcer primarily caused by a medical condition other than diabetes mellitus;\n* inadequate arterial circulation to the foot documented within 28 days prior to Visit 1, or during the screening period:\n\n  * Ankle-brachial Index \\\u003C 0.7 or \\> 1.3 and\u002For\n  * Toe-brachial Index \\\u003C 0.7;\n* presence of acute Charcot's neuro-arthropathy, or osteomyelitis, on the affected foot within 3 months prior to Visit 1;\n* use of wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 14 days prior to Visit 1, or documented intention to use them during the subject's participation;\n* use of any investigational drug(s) or device(s), systemic immunosuppressive treatment (including systemic corticosteroids), or application of topical steroids to the Index ulcer surface, within 28 days prior to Visit 1;\n* use of cytotoxic chemotherapy and\u002For radiotherapy within 6 months prior to Visit 1;\n* known history of bone cancer or metastatic disease of the affected limb;\n* poor nutritional status;\n* presence of an on-going uncontrolled renal, hepatic, cardiovascular or other disease that could pose an additional risk for the participant, or could significantly influence interpretation of the results (as evaluated by the investigator);\n* known history of non-compliance and\u002For presence of any condition(s) seriously compromising the subject's ability to adhere to the procedures required by this Clinical Investigational Plan;\n* pregnant or breast-feeding females;\n* females of childbearing potential not using an effective method of contraception.","ALL","18 Years","85 Years",{"count":202,"type":203},66,"ESTIMATED","INTERVENTIONAL",[206],"NA","The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85 years with diabetes mellitus (type 1 or 2) and with present diabetic foot ulcer by providing moist environment similar to intracellular environment of the damaged tissue. It will also learn about the safety of medical device Berovenal®.\n\nThe main questions it aims to answer are:\n\n* Does medical device Berovenal® lower the size of diabetic foot ulcer?\n* What medical problems do participants have when using medical device Berovenal®?\n\nResearchers will compare medical device Berovenal® to a reference device (device with similar purpose of use).\n\nParticipants will:\n\n* Use medical device Berovenal® or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of their symptoms and the number of times they use medical device Berovenal® or a reference device",[209],"Diabetic Foot Ulcer","2024-09-02",{"date":212,"type":213},"2024-09-05","ACTUAL",{"date":215,"type":213},"2023-05-17",{"date":217,"type":203},"2025-12",{"name":5,"class":6},9]