Polidocanol Foam With or Without Transdermal Laser in Varicose Veins
Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado
Hospital Universitario Pedro Ernesto
102 participants
Mar 24, 2026
INTERVENTIONAL
Conditions
Summary
This randomized, parallel clinical trial with blinded outcome assessment will compare the clinical and aesthetic outcomes of polidocanol foam sclerotherapy alone versus polidocanol foam associated with long-pulse 1064 nm Nd:YAG transdermal laser in the treatment of lower-limb tributary varicose veins. The primary endpoint is venous occlusion rate at 30 days, assessed by Doppler ultrasound. Secondary outcomes include cutaneous hyperpigmentation, pain, patient satisfaction, and adverse events.
Eligibility
Inclusion Criteria8
- Age 21 to 75 years
- CEAP clinical class 1-3
- Lower limb tributary varicose veins 2,5 to 4,0 mm in diameter on Doppler ultrasound.
- Vein depth up to 4 mm from the skin surface.
- Tributary vein may originate from the great or small saphenous vein as long as the saphenous vein is competent on Doppler.
- Reflux limited to the target tributary.
- Body mass index (BMI) < 35 km²/m²
- Able and willing to provide informed consent.
Exclusion Criteria13
- CEAP clinical class ≥ 4
- Axial reflux of the great or small saphenous vein requiring prior treatment
- Tributary vein diameter < 2.5 mm or > 4.0 mm on Doppler
- Tributary vein depth > 4 mm from the skin surface
- Pregnancy or breastfeeding
- Known allergy or hypersensitivity to polidocanol
- History of deep vein thrombosis or pulmonary embolism in the last 6 months
- Use of anticoagulant therapy that cannot be safely interrupted
- Active skin infection or ulcer at the treatment site
- Autoimmune or connective tissue disease with active vasculitis
- BMI ≥ 35 kg/m²
- Inability to comply with follow-up visits
- Previous treatment of the target vein in the past 6 months (laser, foam, surgery, or microphlebectomy).
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Interventions
Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance.
Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.
Locations(1)
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NCT07276243