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New treatment option for Peripheral Arterial Disease
Official title SMART Exercise for PAD
ClinicalTrials.gov ID: NCT06032065
What this study is testing
- What it's testing
- Supervised exercise therapy (SET), consisting of treadmill exercise conducted three times weekly at a center while supervised by healthcare personnel, is first line therapy for people disabled by lower extremity peripheral artery disease (PAD). However, travelling three times/week to a center for SET is burdensome.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as either:
- An ABI \<= 0.90 at baseline.
- Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 0.70 or an ankle brachial index less than or equal to 0.90), or...
- An ABI of \>0.90 and \<1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.
You likely can't join if
- Above- or below-knee amputation
- Limb-threatening ischemia defined as an ABI \<0.40 with symptoms of rest pain
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a condition other than PAD
- Current foot ulcer on bottom of foot
- Unwilling to drink beetroot juice
See the full eligibility criteria
- First, all participants will be age 50 and older. Second, all participants will have PAD. PAD will be defined as either:
- An ABI \<= 0.90 at baseline.
- Vascular lab evidence of PAD (such as a toe brachial pressure less than or equal to 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an...
- An ABI of \>0.90 and \<1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test.
- Above- or below-knee amputation
- Limb-threatening ischemia defined as an ABI \<0.40 with symptoms of rest pain
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a condition other than PAD
- Current foot ulcer on bottom of foot
- Unwilling to drink beetroot juice
- Unwilling to accept randomization into either group (home based exercise or supervised exercise)
- Planning to engage in new walking exercise outside of the study or unwilling to refrain from new walking exercise activity during the trial.
- Already exercising at a level consistent with exercise intervention.
- End-stage kidney disease (ESKD) associated with the need for dialysis.
- Planned major surgery, coronary or leg revascularization during the next six months
- Major surgery, coronary or leg revascularization or major cardiovascular event in the previous three months
- Major medical illness including lung disease requiring oxygen, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. [NOTE...
- Mini-Mental Status Examination (MMSE) score \< 23 or dementia. However, if the MMSE is \< 23 and the Principal Investigator evaluation determines that the lower score is related to language barriers or education level...
- Allergy to beetroot juice
- Currently consuming beetroot juice or oral nitrate or nitrite, or a beetroot supplement, and/or unwilling to avoid these during study participation. Participants currently consuming one cup of beets daily will be asked...
- Unstable angina
- Abnormal baseline stress test without subsequent clearance for exercise by physician
- Non-English speaking. The SMART PAD interventions are delivered by interventionists who do not speak non-English languages. The integrity of the clinical trial requires clear and effective communication for data...
- Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit...
- Visual impairment that limits walking ability.
- Baseline blood pressure \<100/45.
- Participation in a supervised treadmill exercise program or cardiac rehabilitation program in previous three months.
- Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or a mouthwash determined to be bactericidal and unwilling to discontinue.
- An eGFR value \ 5.0.
- History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Minneapolis, Minnesota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.