NCT00182208已完成3 期
Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Clinical Success measured with the Global Rating Instrument
研究概览
简要总结
The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.
详细描述
Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week 'wash out' period.( A randomized controlled 'crossover' study}
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Past History of objectively documented deep vein thrombosis
- •Daily leg swelling with discomfort (i.e. report at least one of the following symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months
- •Over 18 years of age (and of either gender).
- •Villalta score of greater than 14(i.e.severe post phlebitic syndrome)
排除标准
- •Episode of objectively documented deep vein thrombosis occurred less than 6 months before recruitment
- •Subjects report that their symptoms have been unstable (worsening, improving or variable over the previous month).
- •Active venous ulceration
- •Baseline leg circumference greater than 50 cm (cuff will not fit subject)
- •Symptomatic peripheral arterial disease Peripheral neuropathy
结局指标
主要结局
Clinical Success measured with the Global Rating Instrument
次要结局
- PTS-CCS questionnaire
- Villalta Scale
- Veines Quality of Life Questionnaire
研究者
研究点 (2)
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