Intermittent Pneumatic Compression to Improve Revascularization Outcome

Study Overview
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Brief Summary
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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
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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).

Official Title
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Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Intermittent pneumatic leg compressions
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham<br>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. | Device: Sham<br>* Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.<br>|
| Active Comparator: Active Comparator - Intermittent Pneumatic Compression<br>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. | Device: Intermittent pneumatic leg compressions<br>* Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking endurance | Change in 6 Minute Walk Test from baseline to 3 months | Baseline and after 1 and 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle-brachial index (ABI) | Change in ABI from baseline to 3 months | Baseline and after 1 and 3 months of treatment | 
| Toe-brachial index (TBI) | Change in TBI from baseline to 3 months | Baseline and after 1 and 3 months of treatment | 
| Transcutaneous Oxygen Pressure at the dorsum of the foot (TcPO2) | Change in TcPO2 from baseline to 3 months | Baseline and after 1 and 3 months of treatment | 
| Rest leg pain | Change in Visual Analog Scale Pain Scale Ruler score (0-100) from baseline to 3 months. 0mm=no pain, 100mm=extreme pain. | Baseline and after 1 and 3 months of treatment | 
| Calf circumference | Change in calf circumference tape measure measurement from baseline to 3 months | Baseline and after 1 and 3 months of treatment | 
| Vascular Quality of Life Score (VascuQol) | Change in scores for VascuQol Questionnaire from baseline to 3 months. Overall score range is 7-175; higher score means higher quality of life. | Baseline and after 1 and 3 months treatment | 
| Quality of Life Score - Short Form-36 | Change in scores for Short Form-36 Questionnaire from baseline to 3 months. Eight health concepts scored 0-100 range. High score is a more favorable health state. | Baseline and after 1 and 3 months treatment | 
| Blood level marker of coagulation - D-Dimer | Change in D-Dimer levels from baseline to 3 months | Baseline and after 1 and 3 months treatment | 
| Blood level marker of coagulation - PT/INR | Change in PT/INR level from baseline to 3 months | Baseline and after 1 and 3 months treatment | 
| Blood level marker of coagulation - thrombin time | Change in thrombin levels from baseline to 3 months | Baseline and after 1 and 3 months treatment | 
| Blood level marker of fibrinolysis - fibrinogen | Change in fibrinogen levels from baseline to 3 months | Baseline and after 1 and 3 months treatment |