Actively Recruiting
Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease
Led by Northwestern University · Updated on 2025-08-29
230
Participants Needed
4
Research Sites
408 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have peripheral artery disease (PAD), confirmed by one of the following: ankle-brachial index (ABI) ≤ 0.90; or ABI > 0.90 with vascular lab evidence such as toe brachial index (TBI) ≤ 0.70, Duplex showing ≥ 70% artery narrowing, or angiographic evidence of ≥ 70% stenosis in a lower extremity artery.
You will not qualify if you...
- Above- or below-knee amputation.
- Critical limb ischemia or ABI < 0.30 with ischemic symptoms or signs.
- Wheelchair-bound individuals.
- Current foot ulcer on the bottom of the foot.
- Walking limited primarily by a cause other than PAD.
- Failure to complete the study run-in.
- Major surgery, revascularization, or orthopedic surgery within the past 3 months or planned in the next 12 months.
- Major illnesses including Parkinson's disease, lung disease requiring oxygen (except night use), recent cancer treatment, or life expectancy under six months.
- Regular exercisers consistent with the exercise intervention or recent exercise rehabilitation in the past 3 months.
- Recent diagnosis (past 3 months) of acute deep venous thrombosis, pulmonary embolism, or severe heart failure (NYHA Class III or IV).
- Mini-Mental Status Examination (MMSE) score below 23 or dementia.
- Participation in another clinical trial within the past 3 months.
- Non-English speaking.
- Recent or ongoing angina or abnormal treadmill stress test without proof of absent coronary ischemia.
- Ongoing infection of toes, foot, or lower extremity.
- Started cilostazol treatment within the past 3 months.
- Significant peripheral edema (3+ or greater).
- Body mass index (BMI) over 45 kg/m2.
- Significant visual impairment interfering with walking.
- Investigator discretion if trial is unsafe or not suitable for participant.
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
3
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
K
Kathryn Domanchuk, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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