NCT05064176 Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
| NCT ID | NCT05064176 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Lymphoedema of Leg |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2022-02-01 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this research proposal is to investigate * in patients with lymphoedema of the upper limb or lower limb (P) * the added value of reconstructive lymphatic surgery (I) * to the decongestive lymphatic therapy (usual care) (C) * on the lymphoedema-specific quality of life (QoL) (O) * at 18 months post-surgery/ no surgery (T) Consequently, a multicentre pragmatic randomised controlled trial is performed to give an answer on following research question: 'Is, in addition to usual care - i.e. decongestive lymphatic therapy -, reconstructive lymphatic surgery (intervention group) superior to no surgery (control group), for the treatment of upper or lower limb lymphoedema?'
Eligibility Criteria
Inclusion Criteria: * Unilateral or bilateral, primary or secondary lymphoedema of the upper or lower limb * If cancer-related lymphoedema, approval for participation in study from oncological specialist (patient participation has to be discussed during Multidisciplinary Oncological Consult); approval if: * estimated cancer-related survival is ≥3 years * oncological safety is guaranteed: for instance, time interval since radiotherapy/ chemotherapy is ≥3 months * Lymphoedema stage 1 to 2b * Objective diagnosis of lymphoedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of IndoCyanineGreen (ICG) dermal backflow * Score on Lymph-ICF questionnaire at screening: ≥ 25 / 100 (= moderate level of problems in functioning related to the development of lymphoedema) * History of at least 6 months of decongestive lymphatic therapy (DLT) until minimal pitting * Age ≥ 18 years Exclusion Criteria: * Participants with history of liposuction, lymphovenous anastomosis, lymph node transfer * Pregnant participants * Severe obese participants: BMI\>35 * Estimated cancer-related survival is \<3 years and oncological safety is not guaranteed (e.g. interval since radiotherapy/ chemotherapy is \<3 months) * In case of lower limb lymphoedema: presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome * Allergy for ICG, iodine, penicillin and sulphonamides; increased activity of thyroid gland; benign tumour in thyroid; heparin use and severe renal insufficiency
Contact & Investigator
Nele Devoogdt
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT05064176 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoedema of Leg. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05064176 currently recruiting?
Yes, NCT05064176 is actively recruiting participants. Contact the research team at nele.devoogdt@kuleuven.be for enrollment information.
Where is the NCT05064176 trial being conducted?
This trial is being conducted at Ghent, Belgium, Leuven, Belgium, Namur, Belgium.
Who is sponsoring the NCT05064176 clinical trial?
NCT05064176 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Nele Devoogdt at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 180 participants.