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New treatment option for Peripheral Artery Disease
Official title Improving Mobility After Revascularization in Peripheral Artery Disease
ClinicalTrials.gov ID: NCT06686121
What this study is testing
What is Nitrate Rich Beetroot Juice?
Nitrate Rich Beetroot Juice is an investigational medicine, given as an once-daily, being studied as a potential treatment for peripheral artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients.
- 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 18 and older
You may be able to join if
- Successful lower extremity revascularization for disabling PAD performed at least 30 days before baseline testing and between 30 and 100 days before...
You likely can't join if
- History of leg amputation, not including toe and partial foot amputation
- Active gangrene
- Active limb threatening ischemia
- Already exercising at a level consistent with exercise intervention, using investigator discretion.
- Unstable angina
- Unwilling to drink study beverages
See the full eligibility criteria
- Successful lower extremity revascularization for disabling PAD performed at least 30 days before baseline testing and between 30 and 100 days before randomization.
- History of leg amputation, not including toe and partial foot amputation
- Active gangrene
- Active limb threatening ischemia
- Already exercising at a level consistent with exercise intervention, using investigator discretion.
- Unstable angina
- Unwilling to drink study beverages
- Unwilling to adhere to the interventions and complete follow-up testing
- Currently taking sildenafil, tadalafil, or related drugs.
- Unwilling to accept randomization into either group (home-based exercise or attention control)
- Currently consuming beetroot juice, oral nitrate or nitrite, or a beetroot supplement and/or unwilling to avoid beetroot juice during the study. Participants will be asked to discontinue these items for 30 days before...
- History of kidney stones that requires minimized intake of oxalate. Potential participants who need to minimize oxalate intake will be excluded from the trial.
- Baseline blood pressure \<100/45.
- Wheelchair confinement or requiring a walker to ambulate
- Walking is limited by a condition other than PAD
- Current foot ulcer
- Planned major surgery, coronary revascularization, or lower extremity revascularization during the next 12 months
- Major medical illness including lung disease requiring oxygen, Parkinson's disease, or a life-threatening illness with life expectancy less than six months.
- Allergy to beetroot juice
- Currently consuming one cup or more of beets daily. Participants will be asked to decrease beet consumption to less than one cup of beets per day for 14 days before baseline testing and throughout the clinical trial. If...
- Participation in or completion of a clinical trial in the previous three months, using investigator discretion for trials that may not impact study participation or outcome measures of the IMPACT PAD Trial.
- Visual impairment that limits walking ability.
- Unable to communicate in English, unless the participant communicates in Spanish and is enrolled at a site that can deliver the intervention in Spanish. All sites with a Spanish speaking coordinator and interventionist...
- Using a mouthwash containing chlorhexidine or cetylpyridinium chloride or a mouthwash determined to be bactericidal and unwilling to discontinue.
- Planning to begin a supervised treadmill exercise program in the next 12 months.
- Heart attack or stroke in previous three months prior to baseline testing.
- 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
- Tucson, Arizona, United States
- Downey, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Lebanon, New Hampshire, United States
- Pittsburgh, Pennsylvania, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Downey, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Lebanon, New Hampshire, United States; Pittsburgh, Pennsylvania, 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.