Intermittent Pneumatic Compression to Improve Revascularization Outcome

Not Applicable

Completed

Brief 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.

Detailed 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).

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Sham	Sham	Participants will apply Intermittent Pneumatic Compression (IPC) using a customized version of the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The sham device applies a compression sequence of 30 mmHg to the foot, ankle and calf with inflatable cuffs.
Active Comparator - Intermittent Pneumatic Compression	Intermittent pneumatic leg compressions	Participants will apply Intermittent Pneumatic Compression (IPC) using the Arterial Assist Device to both legs for 2 hours daily for a duration of 3 months. The Arterial Assist Device® applies a compression sequence of 120 mmHg to the foot, ankle and calf with inflatable cuffs.

Primary Outcome Measures

Name	Time	Method
Walking Endurance	Baseline and after 1 and 3 months of treatment	Change in 6 Minute Walk Test from baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
Ankle-brachial Index (ABI)	Baseline and after 3 months of treatment	Change in ABI from baseline to 3 months. A handheld 5-MHz Doppler ultrasound (Lumeon, McKesson) was used to obtain duplicate measurements of systolic pressures in the right posterior tibial artery, right dorsalis pedis artery, right brachial artery, left posterior tibial artery, left dorsalis pedis artery, and left brachial artery. The ABI of each leg was calculated by dividing the higher of the dorsalis pedis pressure or posterior tibial pressure by the higher of the right or left arm blood pressure
Toe-brachial Index	Baseline and after 1 and 3 months of treatment	Change in toe-brachial index from baseline to 3 months. A toe-brachial index (TBI) is a non-invasive test that measures the ratio of systolic blood pressure in the toe to the higher systolic pressure in the arm. A toe/digit pressure cuff is wrapped around the measured toe, and a senso is placed on the toe distally to the pressure cuff.
Vascular Quality of Life Score (VascuQol)	Baseline and after 1 and 3 months treatment	Change in scores for VascuQol Questionnaire from baseline to 3 months. Overall score range is 7-175; higher score means higher quality of life.

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