Lymphovenous anastomosis for lower-leg lymphedema
Official title: Protocol: Effect of Lymphovenous Anastomosis in the Treatment of Lower Limb Lymphedema - Pragmatic Assessor-Blinded Open-Label Randomized Controlled Trial (PrCT)
Run by Herlev and Gentofte Hospital · NCT07073586 · Data updated 2026-11-12
This trial will test whether adding lymphovenous anastomosis surgery to ongoing compression care can reduce swelling and improve quality of life for adults with early-stage lower-leg lymphedema who have finished complete decongestive therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 2 sites (Odense, Fyn and 1 other locations) |
| Status | Recruiting |
| Started | May 9, 2025 |
| Main results expected | August 2027 |
| Study ends | August 2029 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT07073586 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with unilateral or bilateral ISL stage 1–2a lower-limb lymphedema who have completed complete decongestive therapy, are cancer-free for at least one year, have BMI ≤28, can undergo general anesthesia and are proficient in Danish are ideal candidates.
✕Probably not a fit
Patients with more advanced lymphedema (ISL stage 2b–3), BMI >28, active cancer, ongoing limb infection or skin disease, prior lymphedema surgery, allergy to ICG, severe cardiopulmonary disease, or other contraindications to anesthesia are excluded and unlikely to benefit from this procedure in the context of the trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicentre, pragmatic randomized trial in Denmark that assigns adults with ISL stage 1–2a lower-limb lymphedema who have completed complete decongestive therapy to either lymphovenous anastomosis (LVA) plus compression care or compression care alone in a 1:1 ratio. Surgeons perform as many super-microsurgical anastomoses as possible using indocyanine green mapping under general anesthesia, and outcomes are measured by independent blinded staff at baseline, 6, 12 and 24 months. The primary outcome is change in L‑Dex ratio at 12 months, with secondary measures including limb volume (tape, perometry, DXA), infection frequency, lymphoscintigraphy, patient-reported outcomes, compression use and anastomosis patency. A small biopsy substudy in ten LVA participants will explore inflammatory and fibrotic tissue changes.
Why it matters
Potential benefit: If successful, LVA added to compression care could reduce limb swelling, lower infection rates and improve mobility and quality of life for people with early-stage lower-leg lymphedema.
How similar studies have gone: Smaller observational and non-randomized series suggest LVA can reduce swelling and infections, but robust randomized evidence for lower-limb lymphedema is currently limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where it's running
-
Department of Plastic Surgery, Herlev and Gentofte Hospital
Herlev, Region Sjælland, Denmark Recruiting -
Department of Plastic Surgery, Odense University Hospital
Odense, Fyn, Denmark Not yet recruiting
Study contacts
- Study coordinator: Amar Bucan, Medical doctor
- Email: amar.bucan.02@regionh.dk
- Phone: +4538685444
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.