RecruitingNot Applicable

Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease

United States230 participantsStarted 2019-01-02

Plain-language summary

The INTERCEDE randomized 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). The INTERCEDE trial will also determine whether intermittent pneumatic compression therapy improves walking endurance at 6-month follow-up, compared to a sham compression therapy. The trial will also determine whether benefits of intermittent pneumatic compression persist after intermittent pneumatic compression treatment is completed.

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Above- or below-knee amputation.
✕. Critical limb ischemia or ABI \< 0.30 in the setting of ischemic symptoms at rest or physical examination findings consistent with critical limb ischemia. Some potential participants with symptoms or signs of critical limb ischemia may be excluded at the principal investigator's discretion if the ABI is 0.30 or higher.
✕. Wheelchair-bound.
✕. Current foot ulcer on bottom of foot.
✕. Walking is primarily limited by a symptom other than PAD.
✕. Failure to successfully complete the study run-in.
✕. Major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months.
✕. Major medical illness including Parkinson's Disease, lung disease requiring oxygen, cancer requiring treatment in the previous two years, or life-threatening illness with a life expectancy of less than six months. Participants who only use oxygen at night will be potentially eligible. \[NOTE: potential participants treated for cancer in the past two years may still qualify if they have had treatment for early stage cancer in the past two years and the prognosis is excellent. Potential participants treated for basal cell or squamous cell skin cancer will not be excluded.\]

What they're measuring

Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only)

Timeframe: Baseline to 6-month follow-up

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

Timeframe: Baseline to 6-month follow-up

Trial details

NCT IDNCT03871075

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Kathryn Domanchuk, BS

312-503-6438 k-domanchuk@northwestern.edu

View on ClinicalTrials.gov More Peripheral Artery Disease trials

Plain-language summary

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Above- or below-knee amputation.
✕. Critical limb ischemia or ABI \< 0.30 in the setting of ischemic symptoms at rest or physical examination findings consistent with critical limb ischemia. Some potential participants with symptoms or signs of critical limb ischemia may be excluded at the principal investigator's discretion if the ABI is 0.30 or higher.
✕. Wheelchair-bound.
✕. Current foot ulcer on bottom of foot.
✕. Walking is primarily limited by a symptom other than PAD.
✕. Failure to successfully complete the study run-in.
✕. Major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months.
✕. Major medical illness including Parkinson's Disease, lung disease requiring oxygen, cancer requiring treatment in the previous two years, or life-threatening illness with a life expectancy of less than six months. Participants who only use oxygen at night will be potentially eligible. \[NOTE: potential participants treated for cancer in the past two years may still qualify if they have had treatment for early stage cancer in the past two years and the prognosis is excellent. Potential participants treated for basal cell or squamous cell skin cancer will not be excluded.\]

What they're measuring

Six-minute walk distance (intermittent pneumatic compression therapy + exercise v. exercise only)

Timeframe: Baseline to 6-month follow-up

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

Timeframe: Baseline to 6-month follow-up