Leg Heat Therapy in Peripheral Artery Disease (NCT05465070)
Leg Heat Therapy to Improve Functional Performance in Peripheral Artery Disease
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Indiana University Health Methodist Hospital — Indianapolis, Indiana
Age range: 50 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Indiana University Health Methodist Hospital — Indianapolis, Indiana
📞 Contact the Study Coordinator
Phone: (317) 274-7440
Email: marshki@iu.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Peripheral Artery Disease
- Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2 — San Francisco, California
- Far Red Light to Improve Functioning in PAD — Birmingham, Alabama
- Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease — Chicago, Illinois
- Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD — Durham, North Carolina
- BEETroot Juice to Reverse Functional Impairment in PAD — Chicago, Illinois
- Exercise Therapy for PAD Using Mobile Health — Decatur, Georgia
Explore by condition: All Peripheral Artery Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.