Intermittent Pneumatic Compression to Improve Revascularization Outcome

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    8
  • sponsor
    Indiana University
Updated on 1 March 2022
angiography
computed tomography angiography
endovascular revascularization
revascularisation
obstructive disease

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 IdentifierNCT04250675
SponsorIndiana University
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 18 years of age
Scheduled for endovascular revascularization of one or both lower extremities

Exclusion Criteria

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
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