Leg Heat Therapy for Peripheral Artery Disease

This study is testing whether a home-based leg heat therapy can improve walking ability and quality of life for people with peripheral artery disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs. You would wear special trousers that circulate warm water (42ºC) for 90 minutes daily over three months. Another group will receive a "sham" treatment where the water is less warm (33ºC). The study aims to enroll 106 participants aged 50 and older who have been diagnosed with PAD based on their ankle-brachial index (ABI) scores. Success will be measured by how much your walking distance improves over 6 minutes after 12 weeks of therapy.

Study design
This is a randomized, double-blind, sham-controlled study involving 106 participants. Participants will be assigned by chance to either the leg heat therapy or the sham control group, and neither you nor the researchers will know which treatment you are receiving.
What's involved
You would apply the leg heat therapy daily for 90 minutes for three consecutive months. Outcomes will be assessed at the start, at the end of the 12-week treatment period, and at a follow-up visit 12 weeks later.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be checked at the end of the 12-week treatment and again 12 weeks after the treatment ends.

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NCT05465070

Leg Heat Therapy in Peripheral Artery Disease

Recruiting
NAAges 50+InterventionalTreatment
Indiana University
~106 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Leg heat therapySham Control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in 6-minute walk distance
Measured over Baseline to 3-month follow-up
Peripheral Artery Disease
1 sites across 1 states
Indiana1

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Eligibility criteria

Inclusion

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

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
  • Change in 6-minute walk distanceBaseline to 3-month follow-up

    The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the 6-minute walk distance at 3-month follow-up compared to a sham treatment.