[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Molnlycke Health Care AB\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":115},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,66,92],{"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":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100595558","an-investigation-to-evaluate-wearing-properties-of-three-different-investigational-devices-100595558","NCT07034014","An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices","A Healthy Volunteer, Single Center, Exploratory Investigation to Evaluate Wearing Properties of Three Different Non-sterile Silicone Self-adhesive Investigational Devices","Inclusion Criteria:\n\n* Participants who are capable and willing to comply with protocol visits, assessments, and instructions.\n* Participants must be in general good health with healthy and intact skin in the test area (as determined by the investigator based on medical history and examination of the application sites).\n* Minimal hairiness at the back (location of the application sites).\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Known allergy\u002Fhypersensitivity to the dressing or its components.\n* Participants with any features at the application sites will be in contact with the adhesive surface of the dressing, and could influence the investigation.\n* Participants not willing to avoid contact of the application sites with water in the morning prior to dressing application and throughout the entire course of the study.\n* Participants not willing to avoid applying any detergents to the application sites in the morning prior to dressing application and throughout the entire course of the study.\n* Participants not willing to avoid the use of leave on cosmetics such as creams\u002Flotions and sunscreens at the application sites 3 days leading up to dressing application and throughout the entire course of the study.\n* Participants not willing to refrain from activities which may directly affect the dressings, application sites or assessments in the morning prior to dressing application and throughout the entire course of the study.\n* Participants whose back is not large enough to accommodate all 12 application sites\n* Any severe systemic disease that may interfere with the performance, evaluation, and outcome of the investigation as judged by the investigator.\n* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and\u002For hormonal treatment within the last 2 years.\n* Active skin disease at the application sites .\n* Any topical medication at the application sites within the last 24 hours prior to the start of the test and\u002For throughout the entire course of the investigation.\n* Pain relief medication on assessment visits . If it is essential for the participant to take pain relief medication on the days mentioned above for any unforeseen reasons, the participant is allowed to use pain relief medication but has to report this to the study center in order to be documented as protocol deviation.\n* Pregnancy or lactation.\n* Drug addicts, alcoholics.\n* AIDS, HIV-positive or infectious hepatitis.\n* Individuals who are inmates in psychiatric wards, prison or state institutions, or any individuals otherwise regarded as vulnerable (as per ISO 14155 Section 3.55).\n* Participation in another investigative drug or device study currently or within the last 30 days.\n* Current participation in a cosmetic study.\n* Employees of the investigation sites directly involved in this clinical investigation.\n* Employees of the sponsor's company.\n* Employees of a competitor company. The participant should not work for any company which produces dressings.\n* The participant is considered by the Investigator to be unsuitable to participate in the investigation for any other reason",true,"70 Years",{"count":51,"type":20},35,[23],"This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.",[55],"Healthy Volunteer Study","RECRUITING","2025-06-13",{"date":59,"type":32},"2025-06-24",{"date":61,"type":32},"2025-06-05",{"date":63,"type":20},"2025-08",{"name":38,"class":39},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100485995","a-clinical-investigation-to-follow-the-progress-of-exuding-chronic-venous-leg-ulcers-using-a-non-bordered-foam-dressing-100485995","NCT05608317","A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing","A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Venous Leg Ulcers Using a Non-Bordered Foam Dressing","Inclusion Criteria:\n\n* Signed consent to participate (including consent for digital imaging)\n* Adult aged ≥18 years\n* Diagnosed with a chronic, exuding VLU\n* Exudate amount moderate to large\n* Wound size from 3 cm2 to 30 cm2, as determined by the clinician\n* ABPI (within 3 months) \\> 0.7. If ABPI \\> 1.4, then big toe pressure \\> 60 mmHg is required or an alternative measurement verifying normal distal arterial flow\n* Willing to be compliant with compression therapy\n\nExclusion Criteria:\n\n* Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment\n* Circumferential wound\n* Known allergy\u002Fhypersensitivity to the materials of the dressing\n* Use of wound fillers",{"count":74,"type":20},20,[23],"The goal of this clinical trial to follow the progress of wounds in those with chronic venous leg ulcers while using a non-bordered foam dressing. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.\n\nParticipants will be asked to wear the dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.",[78,79,80,81],"Wounds","Wound of Skin","Wound Leg","Venous Leg Ulcer",[81],"2024-05-03",{"date":85,"type":32},"2024-05-06",{"date":87,"type":32},"2022-11-08",{"date":89,"type":20},"2024-11-30",{"name":38,"class":39},3,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":5},"100484479","a-clinical-investigation-to-follow-the-progress-of-exuding-chronic-wounds-using-mepilex-up-as-the-primary-dressing-100484479","NCT05588583","A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.","A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up","Inclusion Criteria:\n\n* Signed consent to participate (including consent for digital imaging)\n* Adult aged ≥18 years\n* Diagnosed with a chronic, exuding VLU or DFU\n* Exudate amount moderate to large\n* Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician\n* For VLU: ABPI (within 3 months) \\> 0.7. If ABPI \\> 1.4, then big toe pressure \\> 60 mmHg is required or an alternative measurement verifying normal distal arterial flow\n* For VLU: Willing to be compliant with compression therapy\n\nExclusion Criteria:\n\n* Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment\n* Circumferential wound\n* Known allergy\u002Fhypersensitivity to the materials of the dressing\n* Patients participating in the DIPLO NBF study\n* Use of wound fillers",{"count":100,"type":20},68,[23],"The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit.\n\nParticipants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.",[78,79,80,104,105,81],"Wound; Foot","Diabetic Foot Ulcer",[105,81],"2023-04-18",{"date":109,"type":32},"2023-04-20",{"date":111,"type":32},"2022-10-31",{"date":113,"type":20},"2024-03",{"name":38,"class":39},""]