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New treatment option for Lymphoedema of Leg
Official title Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
ClinicalTrials.gov ID: NCT05064176
What this study is testing
- What it's testing
- 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?'
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Belgium
- Leuven, Belgium
- Namur, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Belgium; Leuven, Belgium; Namur, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.