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Intermittent Pneumatic Compression + Exercise for Peripheral Arterial Disease (INTERCEDE Trial)

N/A

Recruiting

Led By Mary McDermott, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

All participants will have PAD. PAD will be defined as follows: first, an ankle-brachial index (ABI) < or = 0.90 at the baseline study visit is an inclusion criterion for PAD. Second, potential participants with an ABI >0.90 who have vascular laboratory evidence of PAD. Vascular laboratory evidence consists of objective evidence of PAD, including toe brachial index (TBI) < or = 0.70, Duplex measure showing 70% stenosis or greater, or ABI values < 0.90. Abnormal waveforms or pulse volume recordings alone from a non-invasive vascular laboratory test will not be sufficient for enrollment. Third, potential participants with an ABI >0.90 who have angiographic evidence of PAD consisting of a stenosis of 70% or greater in a lower extremity artery.

Be older than 18 years old

Must not have

Non-English speaking

Wheelchair-bound

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will establish whether six-months of intermittent pneumatic compression combined with walking exercise improves walking endurance at six-month follow-up, compared to walking exercise + sham compression therapy, in people with lower extremity peripheral artery disease (PAD).

Who is the study for?

This trial is for individuals with Peripheral Artery Disease (PAD), confirmed by an ankle-brachial index (ABI) of ≤0.90, or other vascular/angiographic evidence. Exclusions include wheelchair users, BMI >45 kg/m2, significant visual impairment affecting walking, non-English speakers, recent amputees or clinical trial participants, certain cognitive impairments and severe medical conditions.

What is being tested?

The INTERCEDE trial tests if intermittent pneumatic compression combined with walking exercise improves walking endurance in PAD patients over six months versus a sham device plus exercise. It also examines the lasting effects after treatment ends.

What are the potential side effects?

While specific side effects are not listed here, interventions like intermittent pneumatic compression and exercise may cause muscle soreness or fatigue. Any discomfort from the sham device should be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PAD based on specific tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I use a wheelchair for mobility.

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My vision problems make it hard for me to walk.

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I have had more chest pain or discomfort in the last month.

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I have severe leg pain due to poor blood flow or my ankle-brachial index is below 0.30.

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I currently have an infection in my foot or lower leg.

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I haven't had major surgery in the last 3 months and don't plan any in the next year.

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I have a current ulcer on the bottom of my foot.

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I have had an amputation above or below the knee.

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My walking is mainly limited by a condition that is not peripheral artery disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Six-minute walk distance (intermittent pneumatic compression therapy alone (without exercise) vs. sham alone (without exercise)

Secondary study objectives

Brachial artery FMD (intermittent pneumatic compression therapy + exercise v. exercise only)

Brachial artery FMD (intermittent pneumatic compression therapy only v. sham only)

Calf muscle perfusion (intermittent pneumatic compression therapy + exercise v. exercise only)

+5 more

Other study objectives

Anti-oxidant enzyme activity (intermittent pneumatic compression therapy + exercise v. exercise only)

Anti-oxidant enzyme activity (intermittent pneumatic compression therapy only v. sham only)

Autophagy (intermittent pneumatic compression therapy + exercise v. exercise only)

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: IPC + exerciseExperimental Treatment2 Interventions

Participants will be asked to wear the intermittent pneumatic compression device for up to three hours daily. They will be helped to engage in home-based walking exercise therapy.

Group II: IPC + "no exercise" controlExperimental Treatment2 Interventions

Participants will be asked to wear the intermittent pneumatic compression device for up to three hours daily. They will be asked to participate in an educational/informational intervention consisting of an attention control intervention

Group III: sham control + exerciseActive Control2 Interventions

Participants will be asked to wear a sham intermittent pneumatic compression device for up to three hours daily. The sham device inflates at the same frequency, but to a much lower systolic pressure, compared to the therapeutic pneumatic compression device. Participants in this group will be helped to engage in home-based walking exercise therapy.

Group IV: sham control + "no exercise" controlActive Control2 Interventions

Participants will be asked to wear a sham intermittent pneumatic compression device for up to three hours daily. The sham device inflates at the same frequency, but to a much lower systolic pressure, compared to the therapeutic pneumatic compression device. Participants will be asked to participate in an educational/informational intervention, designed as an attention control group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health Education

2014

Completed Phase 3

~4410

exercise

2014

Completed Phase 4

~1190