Home-based leg heat therapy for improving walking in patients with peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of home-based leg heat therapy on lower-extremity functioning and quality of life in patients with peripheral artery disease (PAD). A total of 106 participants will be randomly assigned to receive either leg heat therapy or a sham treatment for 90 minutes daily over three months. The primary outcome is the change in 6-minute walk distance, while secondary outcomes include various measures of physical performance, muscle strength, and quality of life. The study aims to provide a feasible therapy option for patients suffering from PAD who may have limited access to traditional treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Indiana University Health Methodist Hospital
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Study coordinator: Kimmy Marshall, RN
• Email: marshki@iu.edu
• Phone: 317-274-7440

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.