[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-ulcers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-ulcers":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100616968","multicenter-randomized-non-inferiority-study-to-compare-the-performance-and-safety-of-debrisoft-duo-with-debrisoft-pad-in-the-debridement-of-wounds-100616968",false,"NCT07312513","Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient is legally capable\n* Patient has signed written informed consent\n* Presence of one of the following wounds\n\n  * Venous lower leg ulcer\n  * Arterial ulcer\n  * Diabetic ulcer\n  * Pressure ulcer\n  * Post-operative wound healing by secondary intention\n  * Traumatic wound\n  * Surgical wound\n  * Burn or scald (grade III: after surgical debridement)\n  * Epidermolysis Bullosa\n* Wound area \\>4cm2\n* The entire wound area can be displayed on one photo from a distance of 25-30 cm\n* Covered with at least 30% debris, necrosis, slough, fibrotic tissue\n\nExclusion Criteria:\n\n* Known allergy and\u002For hypersensitivity to Debrisoft® Duo or any of the product components\n* Pregnancy or breast feeding\n* Patient is illiterate\n* Participation in a interventional clinical trial within the last 14 days and during participation in this study\n* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and\u002F or interpretation of the study results\n* severe pain or hyperesthesia in the wound area\n* history of drug or alcohol abuse\n* chronic analgesic use (especially opioids) that could influence baseline pain perception\n* cognitive impairment, which may affect the ability to accurately self-report pain\n* Use of anaesthesia before the debridment procedure\n* presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary","ALL","18 Years",{"count":18,"type":19},104,"ESTIMATED","INTERVENTIONAL",[22],"NA","The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.",[25,26,27,28,29,30,31,32,33],"Diabetic Ulcers","Arterial Ulcers","Venous Ulcers","Pressure Ulcers","Postoperative Wounds Healing by Secondary Intention","Burns and Scalds","Epidermolysis Bullosa (EB)","Traumatic Wounds","Surgical Wounds",[35,36],"Debridement","mechanical debridement","RECRUITING","2025-12-17",{"date":40,"type":41},"2025-12-31","ACTUAL",{"date":43,"type":41},"2025-05-09",{"date":45,"type":19},"2026-02",{"name":47,"class":48},"Lohmann & Rauscher","INDUSTRY",5,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":20,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100543040","the-role-of-compression-stockings-in-heart-failure-patients-100543040","NCT06350695","The ROle of Compression StocKings in Heart Failure Patients","ROCK-HF","Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of Heart failure NYHA II-III Class A, B, or C.\n* Pitting edema of the lower extremities\n\nExclusion Criteria:\n\n* Peripheral arterial disease with ABI of 0.5 or less\n* Severe decompensated heart failure NYHA IV\n* Unstable acute coronary syndrome\n* Severe valvular stenosis or regurgitation\n* Hypertrophic obstructive cardiomyopathy\n* Unstable arrhythmia without a defibrillator\n* On renal replacement therapy, hemodialysis of peritoneal dialysis\n* Morbid obesity with a BMI \\> 40\n* Pregnancy\n* Lymphedema or Lipoedema\n* Unable to put the compression stockings on by him\u002F herself or a person to do it for the patient\n* Septic phlebitis, acute bacterial, viral or allergic inflammation of the legs\n* Expectancy of life less than 6 months\n* Unable to read or understand English language",{"count":58,"type":19},50,[22],"Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or \"water pills\" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months.",[62,63,64,27],"Heart Failure，Congestive","Leg Edema","Venous Insufficiency",[66,67,68,69,70],"compression stockings","congestive heart failure","venous insufficiency","edema of the legs","venous ulcers","2024-09-30",{"date":73,"type":41},"2024-10-02",{"date":75,"type":41},"2024-01-17",{"date":77,"type":19},"2026-01-01",{"name":79,"class":80},"University of Maryland, Baltimore","OTHER",1]