Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Walking Endurance
研究概览
简要总结
The purpose of this study is to investigate whether daily treatment with intermittent pneumatic leg compressions (IPC) following a nonsurgical vascular procedure improves circulation and enhances walking distance.
详细描述
Restenosis following revascularization procedures occur frequently and as early as 3 months after the intervention. There is an urgent need for adjunctive therapies that aid in the improvement of tissue blood flow and consequently relieve pain and improve functional capacity in these patients. It has been previously shown that exposure to IPC enhances leg blood flow to collateral-dependent tissues. In this study, subjects who have undergone nonsurgical revascularization will be randomly assigned to two groups: IPC or placebo pump. Subjects will receive a commercially available IPC device (Art Assist, ACI Medical, San Marcos, CA) and will apply the treatment at home for 2 hours daily over 3 consecutive months. At 3 time points (pre, 1 and 3 months post procedure) assessments will be performed (hemodynamics, rest pain, calf muscle oxygenation during exercise, walking endurance and quality of life).
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 (Participant)
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
- •At least 18 years of age
- •Scheduled for endovascular revascularization of one or both lower extremities.
排除标准
- •Chronic kidney disease (eGFR <30 by MDRD or Mayo or Cockcroft-Gault formula)
- •Open and/or non-healing wounds in the areas covered by IPC cuff
- •Walking limited by a symptom other than PAD
- •Presence of any clinical condition that makes the patient unsuitable to participate in the trial
- •Concern for inability of the patient to comply with study procedures and/or follow-up
结局指标
主要结局
Walking Endurance
时间窗: Baseline and after 1 and 3 months of treatment
Change in 6 Minute Walk Test from baseline to 3 months
次要结局
- Ankle-brachial Index (ABI)(Baseline and after 3 months of treatment)
- Toe-brachial Index(Baseline and after 1 and 3 months of treatment)
- Vascular Quality of Life Score (VascuQol)(Baseline and after 1 and 3 months treatment)
研究者
Raghu Motaganahalli
Associate Professor
Indiana University