Intermittent Pneumatic Compression to Improve Revascularization Outcome

Indiana University

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Sham; Device: Intermittent pneumatic leg compressions

Study type: Interventional

Funder types: Other

Identifiers

NCT04250675

1907961196

Details and patient eligibility

About

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.

Full 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).

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Sham

Active Comparator - Intermittent Pneumatic Compression

Active Comparator group

Description:

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.

Treatment:

Device: Intermittent pneumatic leg compressions