Leg Heat Therapy in Peripheral Artery Disease

NCT ID: NCT05465070

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2026-12-31

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).

Detailed Description

The lack of accessible therapies amenable for application in the home setting is a major obstacle for treating patients who suffer from lower-extremity peripheral artery disease (PAD). The investigators will determine whether unsupervised, home-based leg heat therapy (HT) improves walking performance compared to a sham intervention. Leg HT will be applied using water-circulating trousers coupled with a water pump and a water heater. Patients will be randomized into one of two groups: those receiving HT (n=53) or those receiving a sham treatment (n=53).The water heater and pump given to participants in the HT group will be adjusted to circulate water at 42ºC through the trousers. In the sham group, water at 33ºC will be circulated through the trousers. Participants will be asked to apply the therapy daily for 90 min for 3 consecutive months. Outcomes will be assessed at baseline, at the completion of the intervention (end of week 12) and at a follow-up visit, 12 weeks after the end of the intervention (week 24). 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, which combines performance in walking speed, standing balance, and repeated chair rises, changes in handgrip strength, perceived 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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Leg heat therapy

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Sham Control

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Raghu Motaganahalli

Professor, Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kimmy Marshall, RN

Role: CONTACT

marshki@iu.edu

317-274-7440

Bruno Roseguini, Ph.D.

Role: CONTACT

brosegui@purdue.edu

(765) 496-2612

Facility Contacts

Janet Klein, RN

Role: primary

jswklein@iupui.edu

317-962-0287

Other Identifiers

1R01AG073634-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13615

Identifier Type: -

Identifier Source: org_study_id