NCT00991497已完成不适用
A Randomised Controlled Trial to Compare the Outcome of Localised Varicosity Compression for 24 Hours and 5 Days After Foam Sclerotherapy to Truncal Varices
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
研究概览
简要总结
The purpose of this study is to compare the results of foam treatment of varicose veins (foam sclerotherapy) in patients who wear compression bandages for 24 hours or 5 days after treatment.
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
- •Proven truncal venous incompetence (of >1 second duration) on venous duplex scanning. (Great saphenous vein (GSV), small saphenous vein (SSV), anterior accessory thigh vein (AATV) or other major tributary).
- •Agreed preference for foam sclerotherapy treatment.
- •Signed consent form agreeing to be part of the trial.
排除标准
- •Total deep venous reflux.
- •Known allergy to liquid sclerosant.
- •Pregnancy or breast feeding.
- •Arterial disease.
研究组 & 干预措施
24 hours compression bandaging
Active Comparator
干预措施: Compression bandaging (Device)
5 days compression bandaging
Active Comparator
干预措施: Compression bandaging (Device)
结局指标
主要结局
Change in Aberdeen Varicose Vein Score from time of treatment to 2 and 6 weeks after treatment
时间窗: 2 and 6 weeks
次要结局
- Change in Burford pain score from time of treatment to 2 and 6 weeks after treatment(2 and 6 weeks)
- Change in SF-36 score from time of treatment to 6 weeks after treatment.(6 weeks)
- Target vein occlusion rate on duplex imaging at 6 weeks(6 weeks)
- Number and type of complications seen(6 weeks)
研究者
研究点 (1)
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