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Polidocanol Foam With or Without Transdermal Laser for Varicose Veins: Randomized Clinical Trial
Sponsor: Hospital Universitario Pedro Ernesto
Summary
This randomized, double-blind, parallel clinical trial 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.
Official title: Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado
Key Details
Gender
All
Age Range
21 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2026-01-01
Completion Date
2027-12-30
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
Polidocanol foam sclerotherapy
Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance.
Transdermal Nd:YAG 1064 nm laser
Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.
Locations (1)
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Rio de Janeiro, Brazil