Actively Recruiting
Leg Heat Therapy in Peripheral Artery Disease
Led by Indiana University · Updated on 2026-01-06
106
Participants Needed
1
Research Sites
216 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
P
Purdue University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Leg Heat Therapy in Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women older than 50 years
- Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg
- Individuals with resting ABI between 0.91 and 1.00 eligible if ABI drops by 20% or more after a heel-rise test
You will not qualify if you...
- Critical limb ischemia with rest pain or non-healing wounds
- Prior foot or leg amputation
- Exercise tolerance limited by conditions other than leg pain (e.g., angina, arthritis, severe lung disease)
- Lower-extremity revascularization or orthopedic surgery within last 3 months
- Use of walking aid other than a cane
- Active cancer
- Chronic kidney disease with eGFR below 30
- Class 2 or 3 obesity (BMI 35 or higher)
- Unable to fit into water-circulating trousers
- Mini-Mental Status Examination score below 23
- Impaired thermal sensation in the leg
- Contraindications to MRI including certain implanted devices, claustrophobia, or inability to lie flat or fit in scanner
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
K
Kimmy Marshall, RN
CONTACT
B
Bruno Roseguini, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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