Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari Method) for Treating Lower Limb Varicose Veins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Vein Occlusion Rate at 30 Days
研究概览
简要总结
This clinical trial aims to assess the efficacy and safety of the SALFOAM 3% method, which involves saline wash, polidocanol 3% foam injection, and extrinsic compression using Lidstop®, in comparison with the conventional Tessari method for the treatment of lower limb varicose veins. The primary objective is to determine whether the SALFOAM 3% method results in better or equivalent vein occlusion rates and fewer adverse effects, such as hyperpigmentation, compared to the standard treatment.
详细描述
Chronic venous disease (CVD) is prevalent in approximately 38% of the adult population in Brazil, posing significant public health challenges due to its potential complications, including ulcerations and reduced quality of life. The SALFOAM 3% method is a novel approach that combines saline wash prior to polidocanol 3% foam sclerotherapy and extrinsic compression with Lidstop®, aiming to improve outcomes by reducing adverse effects such as hyperpigmentation and enhancing patient quality of life. This randomized controlled trial will compare the efficacy, safety, and quality of life outcomes of patients treated with the SALFOAM 3% method versus those treated with the conventional Tessari method for lower limb varicose veins.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older with clinically confirmed varicose veins in the lower limbs by ultrasonography.
- •All Fitzpatrick skin types (I-VI).
- •Ability to provide written informed consent.
排除标准
- •Pregnancy or breastfeeding.
- •Known allergy or adverse reaction to polidocanol or similar agents.
- •Active infection in the area of treatment.
- •Immunosuppressed patients.
- •Severe coagulopathies or a history of recent deep vein thrombosis or pulmonary embolism.
- •Diagnosis of patent foramen ovale.
- •CEAP classification VI (active venous ulcers).
- •Use of medications that may interfere with the study outcomes.
- •Inability to comply with the study protocol or refusal to participate.
结局指标
主要结局
Vein Occlusion Rate at 30 Days
时间窗: 30 days post-procedure
Vein occlusion will be measured using Doppler ultrasound to assess whether the treated veins are completely occluded, partially occluded, or not occluded at 30 days post-procedure.
次要结局
- Hyperpigmentation Rate(7 and 30 days post-procedure)
研究者
Lidiane Rocha
Principal Investigator
Science Valley Research Institute