Intermittent Pneumatic Compression to Improve the Outcome of Revascularization for Severe Peripheral Artery Disease: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Walking Endurance
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Walking Endurance
Time Frame: Baseline and after 1 and 3 months of treatment
Change in 6 Minute Walk Test from baseline to 3 months
Secondary Outcomes
- Ankle-brachial Index (ABI)(Baseline and after 3 months of treatment)
- Toe-brachial Index(Baseline and after 1 and 3 months of treatment)
- Vascular Quality of Life Score (VascuQol)(Baseline and after 1 and 3 months treatment)
Investigators
Raghu Motaganahalli
Associate Professor
Indiana University