[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"compression-bandages\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:compression-bandages":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100640508","a-randomized-non-inferiority-study-of-mepi-press-2-vs-urgok2-for-compression-therapy-in-venous-leg-ulcers-100640508",false,"NCT07600489","A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers","A Comparative, Adaptive, Randomized, Non-Inferiority Clinical Investigation of Two-Layer Compression Bandages Mepi™ Press 2 Versus UrgoK2® in the Treatment of Venous Leg Ulcers","Inclusion Criteria:\n\n* Patients ≥ 18 years.\n* Stage C6 venous leg ulcer diagnosed less than 24 months ago.\n* 2cm² ≤ VLU surface area ≤ 40cm².\n* ABPI equal or higher than 0.8 and equal or lower than 1.3.\n* Able to read, understand and speak French for their medical care.\n* Agreeing to follow the procedures described in the CIP.\n* Benefiting from a social insurance coverage.\n\nExclusion Criteria:\n\n* Any contraindication to investigational or comparator medical devices mentioned in their respective IFUs.\n* Planned endovenous treatment or surgical venous stripping \u002F exeresis within 8 weeks before planned inclusion date, or before end of participation to the study.\n* Treatment with chemotherapy or antineoplastic agent within the last 6 months.\n* Active wound infection or wound infection treatment within the past 4 weeks before inclusion or current use of silver dressings.\n* Pregnant or breastfeeding women.\n* Persons deprived from their liberty.\n* Persons protected under guardianship or curatorship.\n* Any person who, as per investigator's decision, is not suitable to participate in the investigation for any other reason.-","ALL","18 Years",{"count":19,"type":20},386,"ESTIMATED","INTERVENTIONAL",[23],"NA","Venous leg ulcers (VLUs) account for approximately 70% of all lower limb ulcers and affect an estimated 0.032% to 1% of the population in Western countries, corresponding to approximately 265,000 to 650,000 individuals in France. Effective management of VLUs is essential to reduce patient burden and associated healthcare costs. Compression therapy is the cornerstone of VLU treatment , as it improves venous return, reduces oedema, and promotes wound healing. Multilayer compression bandage systems, including two-layer systems, are considered the gold standard, and in France, they are recommended as first-line treatment for VLUs.\n\nThe goal of this clinical trial is to evaluate whether the Mepi™ Press 2 compression system is non-inferior to UrgoK2® in the treatment of venous leg ulcers in adult patients.\n\nThe main question it aims to answer is:\n\n-Is Mepi™ Press 2 non-inferior to UrgoK2® in terms of the proportion of completely healed VLUs within 12 weeks?\n\nResearchers will compare Mepi™ Press 2 with UrgoK2® to determine whether similar clinical efficacy, performance, and safety can be achieved.\n\nParticipants are adult patients with venous leg ulcers of less than 24 months duration requiring treatment with a two-layer compression bandage system. The study is multicenter, involving approximately 25 sites in France, and plans to enroll 386 participants.\n\nParticipants will:\n\n* Receive compression therapy with either Mepi™ Press 2 or UrgoK2® in accordance with standard of care\n* Receive an appropriate primary wound dressing prior to compression\n* Attend up to five study visits over a period of up to 12 weeks (or until wound healing, whichever occurs first)\n* Be assessed for wound healing, safety, and device performance throughout the study",[26,27],"Venous Leg Ulcer (VLU)","Compression Bandages","NOT_YET_RECRUITING","2026-05-13",{"date":31,"type":32},"2026-05-20","ACTUAL",{"date":34,"type":20},"2026-05",{"date":36,"type":20},"2028-05",{"name":38,"class":39},"Molnlycke Health Care AB","INDUSTRY",8,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":5},"100562499","prevention-of-edema-after-coronary-artery-bypass-graft-by-customized-pressure-guided-elastic-bandages-100562499","NCT06603961","Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages","Efficacy of Customized Pressure-Guided Elastic Bandages in Preventing Postoperative Edema and Complications in Coronary Artery Bypass Graft (CABG) Patients: A Comparative Study of Compression Therapy and Standard Post-CABG Care.","PEACCE","Inclusion Criteria:\n\n1. All patients scheduled for elective coronary artery bypass grafting (CABG) surgery with saphenous vein harvesting from the leg at Siriraj Hospital.\n2. Patients aged 18 years and older undergoing CABG surgery with saphenous vein harvesting from the leg at Siriraj Hospital, who willingly consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with an Ankle-brachial pressure index (ABI) \\\u003C 0.8\n2. Patients with severe leg swelling (pitting edema of grade 3 or higher) or with pre-existing or post-operative heart failure that remains uncontrolled despite diuretic therapy.\n3. Patients with occlusive peripheral arterial disease (PAD) or chronic venous insufficiency (CEAP 2s), characterized by significant venous stasis, leg pain, varicose veins, or lymphadenopathy.",true,{"count":51,"type":20},106,[23],"The study aimed to assess the efficacy of customized pressure-guided elastic bandages (CPG-EB) in preventing postoperative edema and complications in Coronary Artery Bypass Graft (CABG) patients. While compression therapy, like compressive stockings, has benefits in preventing edema, concerns about affordability persist. CPG-EB provides optimal sub-bandage pressure, proven effective in venous leg ulcers. Implementing CPG-EB post-CABG could enhance venous blood flow, reducing complications and improving outcomes. Patients were divided into two groups: one with CPG-EB and the other standard post-CABG care. Data collected at 1, 2, and 6 weeks post-surgery assessed swelling and wound complications. Comparative analysis used standardized criteria.",[55,56,57,27,58,59,60,61,62,63,64],"Limb Edema","Surgical Site Infections","Leg Swelling","Coronary Artery Bypass Graft","CABG","Saphenectomy","Saphenous Vein","Delayed Wound Healing","Post Operative Complications","Post Operative Surgical Site Infection",[66,67,68,59,69],"compression bandages","compression therapy","customized pressure-guided elastic bandages","coronary arterial bypass graft","RECRUITING","2026-02-06",{"date":73,"type":32},"2026-02-09",{"date":75,"type":32},"2025-01-19",{"date":77,"type":20},"2026-05-31",{"name":79,"class":80},"Siriraj Hospital","OTHER"]