Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Venous occlusion rate at 30 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Randomization will be performed in a 1:1 ratio using a concealed allocation sequence accessible only at the time of treatment by a staff member not involved in outcome assessment.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Group A: Foam only
Polidocanol 0,5% foam prepared with 1 mL of sclerosant and 3 mL of room air, injected under visualization of reticular vein (5 - 8 mL total).
干预措施: Polidocanol foam sclerotherapy (Drug)
Group B: Foam + Laser
Polidocanol 0,25% foam (1 mL of sclerosant + 2 mL of room air) followed within 2 minutes by long-pulse Nd:YAG 1064 nm laser (spot 6 mm; pulse 20-30 ms; fluence 60-70 J/cm²), with skin cooling.
干预措施: Polidocanol foam sclerotherapy (Drug)
结局指标
主要结局
Venous occlusion rate at 30 days
时间窗: 30 days after the first session
Ultrasound assessment of the treated vein segment 30 days after the first session, defined as complete absence of detectable flow in the treated vein or partial occlusion with significant reduction in reflux and/or venous diameter, and performed by an independent physician who is blinded to group assignment and not involved in the treatment procedures.
次要结局
- Venous occlusion rate at 90 days(90 days after the first session)
- Final venous occlusion rate at 180 days(180 days after the first session)
- Pain intensity immediately after the procedura(Immediately after the procedure (within 30 minutes))
- Number of treatment sessions required(Up to 90 days after the first session.)
- Patient-reported aesthetic satisfaction(Assessed at 90 days after the first session.)
- Hyperpigmentation at the treated site(30, 90, and 180 days after the first session.)
研究者
Juliana de Miranda Vieira
Principal Investigator
Hospital Universitario Pedro Ernesto