[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640508":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":143,"collaborators":145,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":27,"eligibilityCriteria":154,"healthyVolunteers":150,"sex":155,"minAge":156,"maxAge":27,"enrollmentInfo":157,"targetDuration":27,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":27,"overallStatus":167,"whyStopped":27,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Molnlycke Health Care AB","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Mepi™ Press 2- two-layer compression bandage","EXPERIMENTAL","Participants will receive compression therapy using Mepi™ Press 2 in accordance with standard of care for venous leg ulcer (VLU) management. Mepi™ Press 2 is a two-layer, short-stretch compression system consisting of a padded bandage and a cohesive compression bandage with visual application indicator. An appropriate primary wound dressing will be applied prior to compression. Bandages are worn continuously and changed as clinically indicated, typically up to once weekly. The system is intended to provide high working pressure and low resting pressure to support venous return and reduce edema. Single-use, non-sterile device.",[13,14],"Device: Compression bandage system (Mepi™ Press 2)","Device: Wound Dressing Material",{"label":16,"type":17,"description":18,"interventionNames":19},"UrgoK2® - multicomponent, compression system","ACTIVE_COMPARATOR","Participants will receive compression therapy using UrgoK2® in accordance with standard of care for venous leg ulcer (VLU) management. UrgoK2® is a two-layer compression system consisting of a white short-stretch bandage (K-TECH) and a pink\u002Fbeige cohesive long-stretch bandage (Kpress) with visual indicators to support correct application and achieve therapeutic compression (approximately 40 mmHg). An appropriate primary wound dressing will be applied prior to compression. Bandages are worn continuously and changed as clinically indicated, typically up to once weekly. The system is non-sterile, intended for single use, available in different sizes based on ankle circumference.",[20,14],"Device: Compression bandage system (UrgoK2®)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Compression bandage system (Mepi™ Press 2)","A two-layer compression system consisting of a padded bandage and a cohesive short-stretch bandage with visual indicator. Provides therapeutic compression to support venous leg ulcer management. Applied with an appropriate primary wound dressing and changed as clinically indicated.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Compression bandage system (UrgoK2®)","A two-layer compression system composed of a short-stretch bandage and a cohesive long-stretch bandage designed to achieve therapeutic compression (\\~40 mmHg). Used for venous leg ulcer management with an appropriate primary wound dressing.",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Wound Dressing Material","Appropriate primary wound dressing applied prior to compression therapy according to standard of care.",[9,16],[37],{"name":38,"affiliation":39,"role":40},"Arne Böhling","Mölnlycke Health Care AB","STUDY_DIRECTOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":27,"email":46},"Clinical Project Manager","CONTACT","+46 (0)31- 722 31 96","kristina.welinder@molnlycke.com",[48,64,77,89,98,110,122,134],{"facility":49,"status":27,"city":50,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Clinique du Parc-Montpellier","Castelnau-le-Lez","France","FR",{"type":54,"coordinates":55},"Point",[56,57],3.90137,43.63605,{"lat":57,"lon":56},[60],{"name":61,"role":44,"phone":62,"phoneExt":27,"email":63},"Principal Investigator","+33 4 67 33 13 31","c-geri@chu-montpellier.fr",{"facility":65,"status":27,"city":66,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"CHU Michallon Grenoble","Grenoble",{"type":54,"coordinates":68},[69,70],5.71479,45.17869,{"lat":70,"lon":69},[73],{"name":74,"role":44,"phone":75,"phoneExt":27,"email":76},"Coordinating Principal Investigator","+33 (0)4 76 76 75 75","sblaise@chu-grenoble.fr",{"facility":78,"status":27,"city":79,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Clinique du Parc Lyon","Lyon",{"type":54,"coordinates":81},[82,83],4.84789,45.74906,{"lat":83,"lon":82},[86],{"name":61,"role":44,"phone":87,"phoneExt":27,"email":88},"+33 4 49 44 00 90","centreplaieslyon@protonmail.com",{"facility":90,"status":27,"city":79,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Hopital Edouard Herriot_HCL",{"type":54,"coordinates":92},[82,83],{"lat":83,"lon":82},[95],{"name":61,"role":44,"phone":96,"phoneExt":27,"email":97},"+33 4 72 11 80 88","judith.catella@chu-lyon.fr",{"facility":99,"status":27,"city":100,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"CHU Nantes","Nantes",{"type":54,"coordinates":102},[103,104],-1.55336,47.21725,{"lat":104,"lon":103},[107],{"name":61,"role":44,"phone":108,"phoneExt":27,"email":109},"+33 2 40 08 33 33","cecile.durant@chu-nantes.fr",{"facility":111,"status":27,"city":112,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Poitiers Polyclinique","Poitiers",{"type":54,"coordinates":114},[115,116],0.34348,46.58261,{"lat":116,"lon":115},[119],{"name":61,"role":44,"phone":120,"phoneExt":27,"email":121},"+33 5 49 61 70 00","dr.kassab@pdp86.fr",{"facility":123,"status":27,"city":124,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"CHU Toulouse\u002FHopital Rangueil","Toulouse",{"type":54,"coordinates":126},[127,128],1.44367,43.60426,{"lat":128,"lon":127},[131],{"name":61,"role":44,"phone":132,"phoneExt":27,"email":133},"+33 5 61 77 22 33","malloizel-delaunay.j@chu-toulouse.fr",{"facility":135,"status":27,"city":124,"state":27,"zip":27,"country":51,"countryCode":52,"cosmosGeoPoint":136,"geoPoint":138,"contacts":139},"Clinique Pasteur-Toulouse",{"type":54,"coordinates":137},[127,128],{"lat":128,"lon":127},[140],{"name":61,"role":44,"phone":141,"phoneExt":27,"email":142},"+33 5 62 21 31 31","pleger@clinique-pasteur.com",{"type":144,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[146],{"name":147,"class":6},"Euraxi Pharma","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":158,"type":159},386,"ESTIMATED","INTERVENTIONAL",[162],"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",[165,166],"Venous Leg Ulcer (VLU)","Compression Bandages","NOT_YET_RECRUITING","2026-05-13",{"date":170,"type":171},"2026-05-20","ACTUAL",{"date":173,"type":159},"2026-05",{"date":175,"type":159},"2028-05",{"name":5,"class":6},8]