Actively Recruiting
Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial
Led by Herlev and Gentofte Hospital · Updated on 2025-07-31
66
Participants Needed
2
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Outcomes are assessed by independent blinded staff at baseline, 6, 12 and 24 months. A biopsy substudy in ten LVA patients explores inflammatory and fibrotic changes. Primary endpoint is change in L-Dex ratio at 12 months. Secondary endpoints include limb volume, infection rate, lymphoscintigraphy findings, patient-reported outcomes, compression-garment use and anastomosis patency. The trial follows Good Clinical Practice and General Data Protection Regulation (GDPR). Patients are covered by the Danish public patient-compensation scheme. Results will be published regardless of outcome, and control participants may opt for LVA after the 12-month visit.
CONDITIONS
Official Title
Effect of Lymphovenous Anastomosis on Lower Limb Lymphedema: Pragmatic Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with lower-limb lymphedema at International Society of Lymphology stage 1 or 2a, including primary and secondary, unilateral or bilateral
- Cancer-free with no recurrence for at least one year
- Circumference of the affected leg is at least 1 cm larger than the non-affected leg at the most swollen site
- Able to understand Danish and provide informed consent
- Dermal Backflow stage between 0 and 4
You will not qualify if you...
- Lower-limb lymphedema at International Society of Lymphology stage 2b or 3
- Medical conditions that prevent surgery or anesthesia, such as severe heart or lung disease
- Allergy to indocyanine green (ICG)
- Ongoing infections or skin diseases in the affected leg
- Previous lymphedema surgery or treatments like liposuction
- Dermal Backflow stage 5
- Active cancer
- Heart or kidney problems causing leg swelling
- Body mass index over 28 kg/m²
- Current smoker
- Presence of foreign objects in the lower limbs (e.g., metal implants or prostheses)
- Venous insufficiency
- Unilateral lower limb weakness (e.g., after stroke)
- Known iodine allergy
- Leg length difference greater than 1.5 cm
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Plastic Surgery, Odense University Hospital
Odense, Fyn, Denmark, 5
Not Yet Recruiting
2
Department of Plastic Surgery, Herlev and Gentofte Hospital
Herlev, Region Sjælland, Denmark, 2730
Actively Recruiting
Research Team
A
Amar Bucan, Medical doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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