Recruiting

Leg Heat Therapy

Sponsor:

Indiana University

Code:

NCT05465070

Conditions

Peripheral Artery Disease

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Leg heat therapy

Sham Control

Study Details

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).

Conditions

Peripheral Artery Disease

Study ID

NCT05465070

Start date

Nov 7, 2022

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Heat therapy

Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 42ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.

active comparator: Sham Control

Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 33ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.

Interventions

Leg heat therapy

A sous vide heating immersion circulator heats up the water inside the water tank to 42ºC. A water pump circulates temperature-regulated water through the trousers.

Sham Control

A sous vide heating immersion circulator heats up the water inside the water tank to 33ºC. A water pump circulates temperature-regulated water through the trousers.

Primary outcome measure

  • Change in 6-minute walk distance [ Time Frame: Baseline to 3-month follow-up ]

Central Contacts and Locations

Central contacts

Kimmy Marshall, RN

317-274-7440marshki@iu.edu

Bruno Roseguini, Ph.D.

(765) 496-2612brosegui@purdue.edu

Locations

Indiana University Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Janet Klein, RN

317-962-0287jswklein@iupui.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • heat therapy
  • peripheral artery disease
  • walking performance
  • muscle strength

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-17.