Is NCT06032065 recruiting in Minneapolis, MN?

Yes, NCT06032065 is currently recruiting participants at its Minneapolis, MN location. This peripheral artery disease clinical trial is actively enrolling qualified participants.

How do I join the peripheral artery disease clinical trial in Minneapolis?

To join this clinical trial in Minneapolis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Minneapolis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Peripheral Artery Disease Clinical Trial in Minneapolis, MN

About This Peripheral Artery Disease Study in Minneapolis

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. Compared to SET, home-based exercise is more accessible and less burdensome. Yet, evidence-based guidelines recommend SET over home-based exercise for PAD. Walking exercise is first l

Sponsor: Northwestern University

Who Can Participate

Inclusion 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 artery supplying the lower extremities.

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.

Exclusion Criteria

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. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent. Participants who require oxygen only at night may still qualify.\]

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, the Principal Investigator has discretion to allow a participant with MMSE \< 23 to participate, as appropriate.

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 to discontinue beet ingestion for 30 days before baseline testing and throughout the clinical trial. If the potential participant is unwilling to refrain from daily beet consumption of one cup or more, they will not be eligible for the clinical trial.

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 collection and intervention delivery. The trial does not have staff members who are fluent in non-English languages, nor does it have the ability to translate all study materials into other languages.

Participation in or completion of a clinical trial in the previous three months. \[NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.\] Participants in a study that involved up to three single doses of nitrate-rich beetroot juice administered on separate days may participate if a month has passed since their last dose of nitrate-rich beetroot juice.

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 \<30 or potassium \>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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Minneapolis?

Yes, this clinical trial (NCT06032065) has an active research site in Minneapolis, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Peripheral Artery Disease Treatment Options in Minneapolis, MN

If you're searching for peripheral artery disease treatment options in Minneapolis, MN, this clinical trial (NCT06032065) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Minneapolis research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced peripheral artery disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all peripheral artery disease clinical trials near you to find additional studies recruiting in your area.

Peripheral Artery Disease Clinical Trial in Minneapolis, MN

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