Air cuffs boost walking in blocked leg arteries?
NCT ID NCT03871075
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether wearing inflatable leg cuffs (intermittent pneumatic compression) for six months can improve walking distance in people with peripheral artery disease (PAD). Some participants also combine the cuffs with walking exercise. The goal is to see if the cuffs help more than a sham device, and if any benefits last after treatment stops. About 211 adults with PAD are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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211 people
The number who actually took part.
- Started
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Jan 2019
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 1. Above- or below-knee amputation. 2. 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. 3. Wheelchair-bound. 4. Current foot ulcer on bottom of foot. 5. Walking is primarily limited by a symptom other than PAD. 6. Failure to successfully complete the study run-in. 7. Major surgery, revascularization, or orthopedic surgery in the past 3 months or planned in the next 12 months. 8. 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. \[NOTE: potential participants treated for cancer in the past two years may still qualify if they have had treatment for early stage cancer in the past two years and the prognosis is excellent. Potential participants treated for basal cell or squamous cell skin cancer will not be excluded.\] 9. Already exercising at a level consistent with exercise intervention. Current or recent participation in exercise rehabilitation (within the past three months). 10. Recently diagnosed (within the past three months) with acute lower extremity deep venous thrombosis, pulmonary embolism, or severe heart failure (i.e. New York Heart Association (NYHA) Class III or IV). 11. Mini-Mental Status Examination (MMSE) score \<23 or dementia. 12. Participation in or completion of a clinical trial in the previous three months. 13. Non-English speaking. 14. Increase in angina in the past month, angina at rest, or abnormal baseline treadmill stress test. Potential participants may become eligible after an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing (such as a stress test with imaging or a coronary angiogram) from a test performed with their own physician and if they do not have symptoms of unstable angina. The evidence of absent coronary ischemia, based on an imaging stress test or coronary angiogram, must have been performed within the previous year. 15. Ongoing infection of the toes, foot, or lower extremity. 16. Potential participants who started on cilostazol within the last three months. They may be evaluated for eligibility once three months have passed since beginning cilostazol. 17. Significant peripheral edema, defined as 3+ or greater edema severity, as determined by the principal investigator. 18. BMI \>45 kg/M2 19. Significant visual impairment that interferes with walking. 20. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Henry Ford Health
Detroit, Michigan, 48202, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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University of Minnesota
Minneapolis, Minnesota, 55455, United States
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