Intermittent Pneumatic Compression to Improve Revascularization Outcome

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04250675
Study type	Interventional
Source	Indiana University
Contact
Status	Completed
Phase	N/A
Start date	February 1, 2020
Completion date	December 31, 2022

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