[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"VULM s.r.o.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Diabetic Foot Ulcer","RECRUITING","2024-09-02",{"date":31,"type":32},"2024-09-05","ACTUAL",{"date":34,"type":32},"2023-05-17",{"date":36,"type":21},"2025-12",{"name":38,"class":39},"VULM s.r.o.","INDUSTRY",9,""]