[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647294":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":103,"collaborators":107,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":34,"enrollmentInfo":126,"targetDuration":34,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":44,"whyStopped":34,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Universiteit Antwerpen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard chronic edema care with a single compression bandage application","ACTIVE_COMPARATOR","The patients will recieve complex decongestive therapy (Skin care + lymph drainage + compression bandage as a single application\u002Fday + exercises followed by a maintenance phase of 1year.",[13],"Other: Conservative edema treatment (complex decongestive therapy)",{"label":15,"type":16,"description":17,"interventionNames":18},"Chronic edema care with boosted compression bandage applications","EXPERIMENTAL","The patients will recieve complex decongestive therapy (Skin care + lymph drainage + compression bandage as 3 applications\u002Fday + exercises) followed by a maintenance phase of 1year.",[19],"Other: Conservative edema treatment with boosted compression therapy",[21,28],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Conservative edema treatment (complex decongestive therapy)","Conservative decongestive edema treatment with a single application of the compression bandage\u002Fday.",[9],[26,27],"complex decongestive treatment","complex physical therapy",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Conservative edema treatment with boosted compression therapy","Conservative edema treatment with boosted compression therapy (3 applications\u002Fday of the compression bandage)",[15],[33],"Complex physical therapy with boosted compression therapy",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Nick Gebruers, PT, PhD, Professor","CONTACT","+32496184346","nick.gebruers@uantwerpen.be",[42,61,73,88],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Antwerp University Hospital","RECRUITING","Edegem","Antwerp","2650","Belgium","BE",{"type":51,"coordinates":52},"Point",[53,54],4.44504,51.15662,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":34,"email":60},"Gaëtane Stassijns, MD, PhD, professor","+328213000","gaetane.stassijns@uza.be",{"facility":62,"status":44,"city":63,"state":46,"zip":64,"country":48,"countryCode":49,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"University of Antwerp","Wilrijk","2610",{"type":51,"coordinates":66},[67,68],4.39513,51.16734,{"lat":68,"lon":67},[71],{"name":37,"role":38,"phone":72,"phoneExt":34,"email":40},"0496184346",{"facility":74,"status":44,"city":75,"state":76,"zip":77,"country":48,"countryCode":49,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"University Hospital Leuven","Leuven","Brabant","3000",{"type":51,"coordinates":79},[80,81],4.70093,50.87959,{"lat":81,"lon":80},[84],{"name":85,"role":38,"phone":86,"phoneExt":34,"email":87},"Nele PT, PhD, Professor, Devoogdt","+3216 33 22 11","nele.devoogdt@kuleuven.be",{"facility":89,"status":44,"city":90,"state":91,"zip":92,"country":48,"countryCode":49,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Ghent University Hospital","Ghent","East Flanders","9000",{"type":51,"coordinates":94},[95,96],3.71667,51.05,{"lat":96,"lon":95},[99],{"name":100,"role":38,"phone":101,"phoneExt":34,"email":102},"Caren Randon, MD, PhD, professor","+329332 21 11","carend.randon@uzgent.be",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Nick Gebruers","Associate Professor",[108,110,112,114],{"name":109,"class":6},"University Hospital, Ghent",{"name":111,"class":6},"University Hospital, Antwerp",{"name":113,"class":6},"Universitaire Ziekenhuizen KU Leuven",{"name":115,"class":6},"KU Leuven","100647294","boosted-compression-for-lower-limb-chronic-edema-100647294",false,"NCT07708662","Boosted Compression for Lower Limb Chronic Edema","Effectiveness of BoostEd COMpresson for the Treatment of Lower Limb Chronic Edema (BECOME): a Pragmatic Multi-centric Randomized Trial","BECOME","Inclusion criteria:\n\n* Patients suffering from chronic edema ( \\> 3 months) of the lower extremity with a positive pitting sign and a conservative treatment is prescribed.\n\n  -≥ 18 years old\n* BMI is \\\u003C36\n* Able to understand and follow instructions in Dutch\n\nExclusion criteria:\n\n* All treatable causes of chronic edema, such as hormonal disturbances (e.g. thyroid dysfunction), protein abnormalities (especially Albumin), cardiac insufficiency, nephrological conditions, drug-induced edema or peripheral arterial disease.\n* Peripheral arterial disease (ABI \\\u003C 0.55)\n* The patient is allergic for one of the products we use during the treatment, and no alternative is available\n* The patient has wounds at the level of the treated edema zone.\n* The patient is currently receiving treatment within the convention \"lymfoedeem\" according to the Belgian Health insurance (RIZIV-INAMI).\n* The patient is not able to give written consent.","ALL","18 Years",{"count":127,"type":128},160,"ESTIMATED","INTERVENTIONAL",[131],"NA","Patients:\n\nPatients targeted in this proposal comprise individuals afflicted by chronic edema\u002Flymphedema of the lower limbs.\n\nIntervention:\n\nThe intervention entails the incorporation of boosted compression alongside standard care during the intensive treatment phase. Boosted compression involves thrice-daily re-application of a multicomponent short stretch compression bandage, aimed at enhancing the efficacy of compression therapy within edema treatment.\n\nComparison:\n\nComparison will be made between the experimental intervention (boosted compression) and the prevailing standard edema treatment, which adheres to the complex decongestive therapy as stipulated by healthcare services, utilizing a single daily application of compression bandage.\n\nStandard care is administered under the supervision of trained physical therapists, specialized in edema treatment.\n\nOutcome:\n\nPrimary outcomes encompass the determination of:\n\n1. the requisite number of treatment days to attain a non-pitting edema state during the intensive phase of edema treatment; and\n2. the non-inferiority of boosted compression in maintaining reduced edema volume during the maintenance phase assessed at 1y of follow-up.\n\nSecondary outcomes encompass assessments of:\n\nQuality of Life, acceptance, and adherence to boosted compression, alongside evaluations of time and cost-effectiveness associated with its implementation.",[134,135],"Chronic Edema","Lymphedema",[137,138,134,139,135,140],"RCT","Pragmatic","Lower Limb","compression therapy","2026-07-13",{"date":143,"type":144},"2026-07-16","ACTUAL",{"date":146,"type":128},"2026-06",{"date":148,"type":128},"2029-12-31",{"name":5,"class":6},4]