跳至主要内容
临床试验/NCT06962813
NCT06962813已完成不适用

Transdermal Radiofrequency (V ERASER) Versus Polidocanol Sclerotherapy for the Treatment of Reticular Veins and Telangiectasias: A Randomized Controlled Trial (TYPER Trial)

Science Valley Research Institute2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年1月10日最近更新:

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eduardo Ramacciotti

Senior investigator

Science Valley Research Institute

研究点 (2)

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