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Physical Therapy

Active Comparator - Intermittent Pneumatic Compression for Peripheral Arterial Disease

N/A

Waitlist Available

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and after 1 and 3 months treatment

Awards & highlights

Study Summary

This trial looks at whether using a machine to pump up and squeeze the legs can improve circulation and walking distance following a nonsurgical vascular procedure.

Eligible Conditions

Peripheral Arterial Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and after 1 and 3 months treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and after 1 and 3 months treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after 1 and 3 months treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Walking endurance

Secondary outcome measures

Ankle-brachial index (ABI)

Blood level marker of coagulation - D-Dimer

Blood level marker of coagulation - PT/INR

+8 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Comparator - Intermittent Pneumatic CompressionActive Control1 Intervention

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.

Group II: ShamPlacebo Group1 Intervention

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.

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Who is running the clinical trial?

Bruno Roseguini, PhDUNKNOWN

3 Previous Clinical Trials

53 Total Patients Enrolled

3 Trials studying Peripheral Arterial Disease

53 Patients Enrolled for Peripheral Arterial Disease

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,151 Total Patients Enrolled

6 Trials studying Peripheral Arterial Disease

272 Patients Enrolled for Peripheral Arterial Disease

Roseguini, Bruno, PhDINDIV

3 Previous Clinical Trials

53 Total Patients Enrolled

3 Trials studying Peripheral Arterial Disease

53 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial being offered to new participants?

"Affirmative. According to the information posted on clinicaltrials.gov, this trial is actively recruiting new participants as of August 24th 2021; it was first shared on February 1st 2020. The study requires 8 enrollees at a single medical facility."

Answered by AI

What is the cap on participants for this research endeavor?

"Affirmative. Clinicaltrials.gov's data indicates that this medical trial, which was originally published on February 1st 2020, is currently open to participants. 8 individuals will be accepted into the study at a single clinical center."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intermittent Pneumatic Compression to Improve Revascularization Outcome

Raghu Motaganahalli 2020. "Intermittent Pneumatic Compression to Improve Revascularization Outcome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04250675.