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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12-month follow-up
Awards & highlights
INTERCEDE Trial 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.Check my eligibility
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.See study design
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.
INTERCEDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PAD based on specific tests.
INTERCEDE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Six-minute walk distance (intermittent pneumatic compression therapy alone (without exercise) vs. sham alone (without exercise)
Secondary outcome measures
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 moreOther outcome measures
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 moreINTERCEDE 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
~4010
exercise
2014
Completed Phase 4
~1190
intermittent pneumatic compression
2012
N/A
~280
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,021 Total Patients Enrolled
24 Trials studying Peripheral Arterial Disease
4,192 Patients Enrolled for Peripheral Arterial Disease
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,433 Total Patients Enrolled
20 Trials studying Peripheral Arterial Disease
16,365 Patients Enrolled for Peripheral Arterial Disease
Mary McDermott, MD5.01 ReviewsPrincipal Investigator - Northwestern Universtiy
Northwestern University
11 Previous Clinical Trials
1,654 Total Patients Enrolled
11 Trials studying Peripheral Arterial Disease
1,654 Patients Enrolled for Peripheral Arterial Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I use a wheelchair for mobility.You are already exercising regularly or have participated in exercise rehabilitation in the last three months.Your Mini-Mental Status Examination (MMSE) score is less than 23, or you have dementia.My vision problems make it hard for me to walk.I have had more chest pain or discomfort in the last month.I have severe leg pain due to poor blood flow or my ankle-brachial index is below 0.30.You have a body mass index (BMI) higher than 45.I do not have a major illness like Parkinson's or cancer needing recent treatment, but I might use oxygen at night.I have been diagnosed with PAD based on specific tests.I currently have an infection in my foot or lower leg.I started taking cilostazol in the last three months.I haven't had major surgery in the last 3 months and don't plan any in the next year.I was recently diagnosed with a serious heart issue or blood clot in my leg or lungs.I have a current ulcer on the bottom of my foot.You have severe swelling in your arms or legs, as determined by the main doctor in charge of the study.I have PAD, confirmed by an ABI test or other vascular or angiographic evidence.I have had an amputation above or below the knee.You didn't finish the initial part of the study successfully.My walking is mainly limited by a condition that is not peripheral artery disease.
Research Study Groups:
This trial has the following groups:- Group 1: sham control + exercise
- Group 2: IPC + "no exercise" control
- Group 3: IPC + exercise
- Group 4: sham control + "no exercise" control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment of participants in this research?
"Affirmative. The clinicaltrials.gov information depicts that this investigation is currently seeking to recruit participants, starting from its original listing on 2nd of January 2019 with the latest update being 13th November 2022. 230 patients are expected between two sites."
Answered by AI
Are there any opportunities at present to enroll in this experiment?
"According to clinicaltrials.gov, this ongoing medical experiment posted on the 2nd of January 2019 is currently searching for participants and was recently updated on November 13th 2022."
Answered by AI
Who else is applying?
What site did they apply to?
Northwestern University
University of Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
2
What state do they live in?
Texas
Illinois
What questions have other patients asked about this trial?
How long do you walk for each day ? I am diabetic and had a lumpectomy on 1/27/2022. Does that disqualify me?
PatientReceived no prior treatments
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