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NOT YET RECRUITING
NCT07276243
NA

Polidocanol Foam With or Without Transdermal Laser for Varicose Veins: Randomized Clinical Trial

Sponsor: Hospital Universitario Pedro Ernesto

View on ClinicalTrials.gov

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

DRUG

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.

DEVICE

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