Intermittent Pneumatic Compression to Improve Revascularization Outcome
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- STATUS
- Recruiting
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- End date
- Dec 31, 2022
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- participants needed
- 8
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- sponsor
- Indiana University
Summary
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.
Description
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).
Details
| Condition | Peripheral Arterial Disease |
|---|---|
| Treatment | SHAM, Intermittent pneumatic leg compressions |
| Clinical Study Identifier | NCT04250675 |
| Sponsor | Indiana University |
| Last Modified on | 1 March 2022 |
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