NCT05465070 Leg Heat Therapy in Peripheral Artery Disease
| NCT ID | NCT05465070 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Peripheral Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2022-11-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2022-11-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from lower-extremity peripheral artery disease (PAD). We will randomize 106 patients to one of two groups that either receive leg HT or a sham intervention. The primary study outcome is the change in 6-minute walk distance between baseline and the 12-week follow up. Secondary outcomes include changes in the short physical performance battery score, handgrip strength, quality of life (measured by the Walking Impairment Questionnaire and Short-Form (SF)-36 Questionnaire), calf muscle strength (measured using a calf ergometer), size (measured by magnetic resonance imaging) and bioenergetics (assessed using phosphorus-31 magnetic resonance spectroscopy), and physical activity (measured by accelerometer).
Eligibility Criteria
Inclusion Criteria: * Men and women older than 50 years * Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg. Individuals with a resting ABI between 0.91 and 1.00 at baseline will be eligible if their ABI drops by 20% or greater following a heel-rise test. Exclusion Criteria: * Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss) * Prior foot or leg amputation * Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc). * Recent (\<3 months) lower-extremity revascularization or orthopedic surgery * Use of walking aid other than a cane * Active cancer * Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula) * Class 2 or 3 obesity (BMI ≥ 35 kg/m2) * Unable to fit into water-circulating trousers * A Mini-Mental Status Examination score \<23 * Impaired thermal sensation in the leg As this study involves MR imaging, patients that have contraindications to MRI will be included in the study but will not be allowed to participate in the MRI experiment. Information about biomedical devices that may pose a risk to patients undergoing MRI is available on the Internet at www.MRIsafety.com. These exclusions include: cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant and history of claustrophobia or who are unable to lie flat or who do not fit inside the bore of the scanner.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05465070 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Peripheral Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05465070 currently recruiting?
Yes, NCT05465070 is actively recruiting participants. Contact the research team at marshki@iu.edu for enrollment information.
Where is the NCT05465070 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT05465070 clinical trial?
NCT05465070 is sponsored by Indiana University. The trial plans to enroll 106 participants.