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New treatment option for Lymphedema
Official title Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07073586
What this study is testing
- What it's testing
- This multicentre pragmatic randomised controlled trial evaluates lymphovenous anastomosis (LVA) for lower-limb lymphedema (LLL) in Denmark. Adults with unilateral or bilateral International Society of Lymphology (ISL) stage 1-2a LLL who have completed protocol-defined Complete Decongestive Therapy (CDT) are randomised 1:1 to Intervention arm - LVA surgery plus ongoing compression care Control arm - Compression care only Recruitment takes place at the Departments of Plastic Surgery, Herlev-Gentofte Hospital and Odense University Hospital.
- 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
- LLL International Society of Lymphology (ISL) stage 1-2a (both primary and secondary lymphedema and both unilateral and bilateral)
- Cancer-free with no recurrence for at least one year
- Age 18 or above
- Circumference of the affected leg is at least 1 cm larger than the non-lymphedema leg at the most affected site of lymphedema.
- Proficiency in Danish language, and ability to provide informed consent.
You likely can't join if
- LLL International Society of Lymphology (ISL) stage 2b-3
- Medical conditions contraindicating surgical intervention or anesthesia, such as severe heart or lung disease
- Allergy to ICG
- Ongoing infections or skin diseases in the affected limb
- Previous surgery or other treatment modalities that could interfere with the study results (previous LVA, liposuction or similar).
- Dermal Backflow Stage 5
See the full eligibility criteria
- LLL International Society of Lymphology (ISL) stage 1-2a (both primary and secondary lymphedema and both unilateral and bilateral)
- Cancer-free with no recurrence for at least one year
- Age 18 or above
- Circumference of the affected leg is at least 1 cm larger than the non-lymphedema leg at the most affected site of lymphedema.
- Proficiency in Danish language, and ability to provide informed consent.
- Dermal Backflow Stage 0-4
- LLL International Society of Lymphology (ISL) stage 2b-3
- Medical conditions contraindicating surgical intervention or anesthesia, such as severe heart or lung disease
- Allergy to ICG
- Ongoing infections or skin diseases in the affected limb
- Previous surgery or other treatment modalities that could interfere with the study results (previous LVA, liposuction or similar).
- Dermal Backflow Stage 5
- Active cancer
- Heart or kidney conditions that can cause leg swelling
- A BMI above 28 kg/m²
- Current smoker
- Any foreign objects in the lower extremities (e.g., metal implants, prostheses)
- Venous insufficiency Unilateral weakness in the lower extremity (e.g., after a stroke)
- Known iodine allergy (contraindication for ICG injection)
- Leg length discrepancy (anisomelia) \> 1.5 cm
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Fyn, Denmark
- Herlev, Region Sjælland, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Odense, Fyn, Denmark; Herlev, Region Sjælland, Denmark. 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.