N/A N=9 Randomized Single-blind Treatment

Intermittent Pneumatic Compression to Improve Revascularization Outcome

Peripheral Arterial Disease

Bottom Line

View on ClinicalTrials.gov: NCT04250675 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Aug 2024

Primary outcome: Primary: Walking Endurance — -14; 35 Meters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Intermittent pneumatic leg compressions (Device); Sham (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Walking Endurance	-14; 35	—
SECONDARY Ankle-brachial Index (ABI)	0.04; -0.03	—
SECONDARY Vascular Quality of Life Score (VascuQol)	0.07; 0.22	—
SECONDARY Toe-brachial Index	0.04; -0.03	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04250675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.