Intermittent Pneumatic Compression to Improve Revascularization Outcome

Indiana University9 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Intermittent pneumatic leg compressionsDEVICE

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.

ShamDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IU Health Methodist

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Walking Endurance

Change in 6 Minute Walk Test from baseline to 3 months

Time frame: Baseline and after 1 and 3 months of treatment

Secondary Outcomes

Ankle-brachial Index (ABI)

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

Time frame: Baseline and after 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.

Time frame: Baseline and after 1 and 3 months treatment

Toe-brachial Index

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.

Time frame: Baseline and after 1 and 3 months of treatment

Data from ClinicalTrials.gov

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