[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637615":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":107,"collaborators":25,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":25,"enrollmentInfo":121,"targetDuration":25,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":137,"whyStopped":25,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Université Libre de Bruxelles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group: Traditional multicomponent bandages","ACTIVE_COMPARATOR","Control group: Traditional multicomponent bandages Patients in the control group will receive the standard inpatient intensive treatment for lower limb lymphoedema including: compression, manula lymphatci drainage, skin care and exercise",[13],"Device: Control group: Traditional multicomponent bandages",{"label":15,"type":16,"description":17,"interventionNames":18},"DDS group: Dynamic compression device (DDS)","EXPERIMENTAL","DDS group: Dynamic compression device (DDS) Patients in the DDS group will undergo the standard inpatient intensive treatment for lower limb lymphoedema including compression therapy, manual lymphatic drainage, skin care and exercise.",[19],"Device: DDS group: Dynamic compression device (DDS)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","In the control group, patients will wear traditional multicomponent bandages as a compression therapy modality 24\u002F24 during the first 5 days of intensive treatment",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients in the DDS group will wera the inverventional dynamic compression device as a compression modality 24\u002F24 during the first five days of inpatient intensive treatment.",[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",[40,64,84],{"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},[74,78,81,83],{"name":75,"role":32,"phone":76,"phoneExt":25,"email":77},"Julie Malloizel, MD","+33 668 91 58","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":82,"role":61,"phone":25,"phoneExt":25,"email":25},"Juile Malloizel, MD",{"name":79,"role":63,"phone":25,"phoneExt":25,"email":25},{"facility":85,"status":25,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Lympho-Opt Fachklinik fur Lymphologie","Pommelsbrunn","Bavaria","91224","Germany","DE",{"type":47,"coordinates":92},[93,94],11.51101,49.50437,{"lat":94,"lon":93},[97,101,105,106],{"name":98,"role":32,"phone":99,"phoneExt":25,"email":100},"Franz-Josef Schingale, MD","+49 9154 911 200","franz-josef.schingale@lympho-opt.de",{"name":102,"role":32,"phone":103,"phoneExt":25,"email":104},"Britta Bockelmann, MD","+49 (0)178 628 5376","info@drb-bodensee.de",{"name":98,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":102,"role":63,"phone":25,"phoneExt":25,"email":25},{"type":108,"investigatorFullName":109,"investigatorTitle":110,"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)","100637615","assessment-of-the-efficacy-of-the-dynamic-decongestive-system-in-the-intensive-phase-of-lower-limb-lymphedema-100637615",false,"NCT07622615","Assessment of the Efficacy of the Dynamic Decongestive System in the Intensive Phase of Lower Limb Lymphedema","A Multicenter Controlled Randomised Clinical Trial to Assess the Efficacy of the Dynamic Decongestive System During the Intensive Phase of Lower Limb Lymphedema Treatment","EDYDES-int","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Men and women\n* Unilateral lower limb lymphoedema of stage II or III according to the criteria defined by the International Society of Lymphology\n* Relative volume difference between affected and healthy leg ≥ 10%\n* Patients requiring intensive decongestive treatment in a hospital setting\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 lymphoedema 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* Deep\u002FSuperficial active or recent venous thrombosis, phlegmasia ceruela dolens (painful blue inflammation), septic\u002Facute thrombophlebitis of the limb (in the last 6 months), active venous leg ulcers\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)\n* Pulmonary edema\n* Cardiac insufficiency (compensated or decompensated)\n* Implantable stimulation devices such as pacemaker\n* Chronic kidney disease with acute renal failure\n* Epilepsy\n* Poorly controlled asthma\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\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":122,"type":123},110,"ESTIMATED","INTERVENTIONAL",[126],"NA","The goal of this study is to compare the efficacy of a dynamic compression device (DDS) with traditional multicomponent bandages (TMCB) in terms of excess volume reduction in lower limb lymphoedema during the first 5 days of intensive treatment.\n\nParticipants in both groups will undergo the standard decongestive treatment protocol of the trial site. The only difference between both groups will be the modality of the compression therapy:\n\n* the intervention (DDS) group will wear the compression 24\u002F24 during the first 5 days of intensive treatment\n* the control group will wear TMCB 24\u002F24 during the first 5 days of intensive treatment (i.e. the standard treatment)",[129],"Lymphedema Lower Extremity",[131,132,133,134,135,136],"Complex decongestive therapy","Dynamic compression","Non-inferiority trial","Lymphoedema maintenance treatment","Limb volume reduction","Limb volume maintenance","NOT_YET_RECRUITING","2026-05-27",{"date":140,"type":141},"2026-06-03","ACTUAL",{"date":143,"type":123},"2026-07-01",{"date":145,"type":123},"2027-12-30",{"name":109,"class":6},3]