Transdermal Radiofrequency (V ERASER) Versus Polidocanol Sclerotherapy for the Treatment of Reticular Veins and Telangiectasias: A Randomized Controlled Trial (TYPER Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Photographic analysis
研究概览
简要总结
This study tested V Eraser, Transdermal radiofrequency versus polidocanol sclerotherapy for the treatment of reticular veins and telangiectasia of the legs
详细描述
Chronic Venous Disease causes symptoms such as pain, edema, and skin manifestations, including telangiectasias and varicose veins. Sclerotherapy with polidocanol is the gold standard treatment; however, technologies such as laser devices and transdermal radiofrequency are also available. The V Eraser, a device that combines transdermal radiofrequency and sclerotherapy, was developed to treat these conditions.
Methods: This was a prospective, randomized, and comparative study comparing V Eraser with sclerotherapy for the treatment of telangiectasias and reticular veins. Forty-one patients were randomized to either V Eraser or polidocanol sclerotherapy and underwent a single treatment session. Efficacy was assessed using the Aberdeen Varicose Vein Questionnaire and vessel clearance analysis in pre- and post-treatment images.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to sign informed consent
- •Patients from 18 to 80 years old with CVD classified as CEAP clinical classes C1 to C5, but only telangiectasias and reticular veins not connected to larger varicosities
排除标准
- •Patients with great saphenous or small saphenous vein insufficiency.
- •Patients with allergies to polidocanol
- •Patients with contraindications to treat varicose veins
结局指标
主要结局
Photographic analysis
时间窗: 30 days
Image analysis of photos was performed on day 30. Using the ImageJ software, two blinded evaluators analyzed the pre- and post-procedure photographs, measuring the vessel lengths in both images
Aberdeen AVVQ questionnaire
时间窗: 30 days
The Aberdeen Varicose Vein Questionnaire (AVVQ) was applied on day 30
次要结局
未报告次要终点
研究者
Eduardo Ramacciotti
Senior investigator
Science Valley Research Institute
