NCT01420289已完成不适用
A Randomized, Controlled Trial to Evaluate High Pressure Rapid Sequence, Intermittent Pneumatic Compression (HPIPC) for the Treatment of Intermittent Claudication, Pain and Ulcer Healing in Subjects With PAD
Calvary Hospital, Bronx, NY2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Mean Percent Reduction in Wound Surface Area
研究概览
简要总结
To evaluate the effects of HPIPC for the treatment of symptoms of PAD
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
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent claudication >6mo
- •Ischemic ulceration or ulcer of mixed (venous) etiology
- •ABI < 0.7
- •Ambulatory
- •Able to comply
排除标准
- •M.I. within 6mo
- •Inability to walk
- •Wound infection
- •Systemic corticosteroids
- •HBO, Apligraf, Dermagraft within 6mo
- •Falsely elevated ankle to brachial index (ABI)
- •Inflammatory condition affecting healing
结局指标
主要结局
Mean Percent Reduction in Wound Surface Area
时间窗: baseline and 16 weeks
次要结局
- Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.(16 weeks)
- Percent Improvement in Peak Walking Time(16 weeks)
- Perceived Improvement in Physical Function After 16 Weeks(16 weeks)
研究者
Oscar M. Alvarez, PhD
Director, Center for Curative andPalliative Wound Care
Calvary Hospital, Bronx, NY
研究点 (2)
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