Polidocanol Foam With or Without Transdermal Laser in Varicose Veins

Официальное название

Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado

Обзор

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.

Подробное описание

The study aims to evaluate whether the association of transdermal Nd:YAG 1064 nm laser with polidocanol foam improves venous occlusion and aesthetic outcomes compared to foam alone. Participants will be adult patients with lower limb varicose veins CEAP 1-3 confirmed by Doppler ultrasound. After randomization (1:1), the control group will receive 0.5% polidocanol foam, while the intervention group will receive 0.25% polidocanol foam followed by transdermal laser application. A second session will be performed only if partial occlusion persists at the 30-day follow-up. Assessments will include venous occlusion at 30, 90 and 180 days after the procedure, pigmentation, pain intensity, number of sessions required, patient satisfaction, and adverse events. Standardized photographs will be taken at baseline, 30, 90 and 180 days.

Вмешательства

• Препарат 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.
• Устройство Transdermal Nd:YAG 1064 nm laser
  Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.

Первичные конечные точки

• Venous occlusion rate at 30 days [Срок оценки: 30 days after the first session]

Вторичные конечные точки (6)

• Venous occlusion rate at 90 days [Срок оценки: 90 days after the first session]
• Final venous occlusion rate at 180 days [Срок оценки: 180 days after the first session]
• Pain intensity immediately after the procedure [Срок оценки: Immediately after the procedure (within 30 minutes)]
• Hyperpigmentation at the treated site [Срок оценки: 30, 90, and 180 days after the first session.]
• Number of treatment sessions required [Срок оценки: Up to 90 days after the first session.]
• Patient-reported aesthetic satisfaction [Срок оценки: Assessed at 90 days after the first session.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Hospital Universitário Pedro Ernesto - UERJ — Rio de Janeiro

Идентификаторы

NCT: NCT07276243 · HUPE-Varizes-Laser-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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