[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638299":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":106,"collaborators":25,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":112,"sex":118,"minAge":119,"maxAge":25,"enrollmentInfo":120,"targetDuration":25,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":136,"whyStopped":25,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Université Libre de Bruxelles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group: Currently available compression devices","ACTIVE_COMPARATOR","Control group: Currently available compression devices Patients in the control group will structure the maintenance phase treatment of their lower limb lymphoedema depending on personal preferences and the recommendations of their treating physician(s).",[13],"Device: Control group: Currently available compression devices",{"label":15,"type":16,"description":17,"interventionNames":18},"DDS group: Dynamic compression device (DDS)","EXPERIMENTAL","Patients in the DDS group will structure the maintenance phase of thier lower limb lymphodema treatment depending on their personal preferences and the recommendations of their treating physician(s).",[19],"Device: DDS group: Dynamic compression device (DDS)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Participant in the control group may use all currently available compression devices to treat their lymphoedema, in addition to the prescribed elastic garment(s).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients in the DDS group are limited to using the DDS device for a minimum of 2h at the end of the day as an adjuvant compression modality to the prescribed elastic garment(s).",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Prof. Jean-Paul Belgrado, PhD","CONTACT","+33 6 38 39 79 56","jp.belgrado@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Velika V Stoitchkova, MSc","+359 882 40 55 33","velika.stoichkova@gmail.com",[40,64,83],{"facility":41,"status":25,"city":42,"state":25,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"CHU Montpellier - Saint Eloi","Montpellier","34090","France","FR",{"type":47,"coordinates":48},"Point",[49,50],3.87635,43.61093,{"lat":50,"lon":49},[53,57,60,62],{"name":54,"role":32,"phone":55,"phoneExt":25,"email":56},"Sandrine Mestre, MD","+33 467 33 70 28","s-mestre@chu-montpellier.fr",{"name":58,"role":32,"phone":55,"phoneExt":25,"email":59},"Isabelle Quéré, Prof","i-quere@chu-montpellier.fr",{"name":54,"role":61,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":58,"role":63,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"facility":65,"status":25,"city":66,"state":25,"zip":67,"country":44,"countryCode":45,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"CHU Toulouse - Rangueil","Toulouse","31059",{"type":47,"coordinates":69},[70,71],1.44367,43.60426,{"lat":71,"lon":70},[74,78,81,82],{"name":75,"role":32,"phone":76,"phoneExt":25,"email":77},"Julie Malloizel, MD","+33 668 91 58 67","malloizel-delaunay.j@chu-toulouse.fr",{"name":79,"role":32,"phone":76,"phoneExt":25,"email":80},"Alessandra Bura-Rivière, Prof","bura-riviere.a@chu-toulouse.fr",{"name":75,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":79,"role":63,"phone":25,"phoneExt":25,"email":25},{"facility":84,"status":25,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Lympho-Opt Fachklinik fur Lymphologie","Pommelsbrunn","Bavaria","91224","Germany","DE",{"type":47,"coordinates":91},[92,93],11.51101,49.50437,{"lat":93,"lon":92},[96,100,104,105],{"name":97,"role":32,"phone":98,"phoneExt":25,"email":99},"Franz-Josef Schingale, MD","+49 9154 911 200","franz-josef.schingale@lympho-opt.de",{"name":101,"role":32,"phone":102,"phoneExt":25,"email":103},"Britta Bockelmann, MD","+49 (0)178 628 5376","info@drb-bodensee.de",{"name":97,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":101,"role":63,"phone":25,"phoneExt":25,"email":25},{"type":107,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Jean-Paul Belgrado","Professor, Coordinator of the Lymphology and Rehabilitation Research Unit, Université libre de Bruxelles (ULB)","100638299","assessment-of-the-efficacy-of-the-dynamic-decongestive-system-in-the-maintenance-phase-of-lower-limb-lymphedema-100638299",false,"NCT07603531","Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema","A Multicenter Controlled Randomised Clinical Trial to Assess the Efficacy of the Dynamic Decongestive System During the Maintenance Phase of Lower Limb Lymphedema Treatment","EDYDES-maint","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Men and women\n* Unilateral lower limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology\n* Patients completing an inpatient intensive treatment phase, including patients participating in CIV-25-01-050914, with a minimum of 20% of excess volume reduction\n* Patients who have given their informed consent freely and signed it prior to any intervention in the study.\n* Patients with a morphology compatible with the perimetric coverage of the device (calf and thigh).\n* Patients able to use the device\n* Patients enrolled in a social security plan or covered by similar health insurance.\n\nExclusion Criteria:\n\n* Patients with suspended lymphoedema of the thigh (unaffected calf and foot)\n* Patients with lipedema\n* Patients with bilateral lower limb lymphoedema\n* Patients with a lymphedema associated with active cancer requiring acute chemotherapy, or oncologic relapses, or treatment in progress\n* Patients with contraindications for compression on the lower limbs such as stent\u002Farterial graft in the area under compression\n* Peripheral artery disease ABI ≤ 0.6\n* Advanced diabetic microangiopathy\n* Active deep\u002Fsuperficial active or recent venous thrombosis, phlegmasia ceruela dolens (painful blue inflammation), active venous leg ulcers, septic\u002Facute thrombophlebitis of the limb (in the last 6 months)\n* A condition where increased venous or lymphatic return is undesirable\n* Neurological disease (including neurogenic diabetic foot, severe peripheral neuropathy of the limb)\n* Pulmonary embolism (last 6 months), pulmonary edema, poorly controlled asthma\n* Cardiac insufficiency (compensated or decompensated)\n* Implantable stimulation devices such as pacemaker\n* Chronic kidney disease with acute renal failure\n* Open skin lesions or skin and subcutaneous infection (cellulitis, erysipelas, lymphangitis, etc.)\n* Skin atrophy of the limb\n* Bullous dermatoses\n* Presence of subcutaneous osteosynthesis material with an external component lying subdermally at the level of the treated lower limb\n* Hyperalgesia of the foot, knee or hip\n* Patients with a known allergy to the components used in the device\n* Patients with psychiatric, psychological, or neurological disorders\n* Patients with impaired cognitive or motor skills and dependent individuals\n* Patients participating in another clinical trial\n* Pregnant or breastfeeding women. Women of childbearing potential will undergo Clearblue® urine pregnancy testing prior to enrollment to verify eligibility.\n* Vulnerable patients, adults being the object of a legal protective measure or unable to express their consent\n* Patients unable to submit to the constraints of the protocol","ALL","18 Years",{"count":121,"type":122},98,"ESTIMATED","INTERVENTIONAL",[125],"NA","The trial aims to determine whether the dynamic compression device, used in combination with elastic compression garments, is non-inferior to currently available compression devices (CACD) during the maintenance phase of lower-limb lymphoedema treatment.\n\nThis is a two-arm, parallel-group trial. Both groups will include patients being discharged after the inpatient intensive treatment phase for lower-limb lymphoedema. Eligible participants will be enrolled on the afternoon of their final inpatient treatment day, prior to discharge.\n\nParticipants will be allocated to one of the following groups:\n\nDDS group: elastic compression garment worn at least during the day and as often as possible during the night, according to patient preference and expert advice, plus DDS use for a minimum of 2 hours at the end of the day, used alone without an elastic garment.\n\nControl group: elastic compression garment worn at least during the day and as often as possible during the night, according to patient preference and expert advice, plus currently available compression devices, including multicomponent bandages, pneumatic compression devices, and compression wraps, according to patient preference and the center's recommendations.\n\nManual lymphatic drainage will be permitted in both groups.\n\nPatients will undergo three assessment visits:\n\nVisit 1 \u002F Baseline-Inclusion (V1): afternoon of the final inpatient treatment day, prior to discharge from intensive treatment; Visit 2 (V2): end of week 6, ± 7 days; Visit 3 (V3): end of week 12, ± 7 days.",[128],"Lymphedema Lower Extremity",[130,131,132,133,134,135],"Complex decongestive therapy","Dynamic compression","Non-inferiority trial","Lymphoedema maintenance treatment","Limb volume reduction","Limb volume maintenance","NOT_YET_RECRUITING","2026-05-27",{"date":139,"type":140},"2026-06-01","ACTUAL",{"date":142,"type":122},"2026-07-01",{"date":144,"type":122},"2027-09-30",{"name":108,"class":6},3]