Leg Heat Therapy in Peripheral Artery Disease

NCT05465070 | Recruiting DMC FDA Device

• 2 other identifiers: 136151R01AG073634-01A1
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in 6-minute walk distance

  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.

  Baseline to 3-month follow-up

Secondary Outcomes (10)

• Change in Walking Impairment Questionnaire (WIQ) score

  Baseline to 3-month follow-up

• Change in Short-Form (SF)-36 Questionnaire score

  Baseline to 3-month follow-up

• Change in Short Physical Performance Battery (SPPB) score

  Baseline to 3-month follow-up

• Change in handgrip strength

  Baseline to 3-month follow-up

• Change in systolic blood pressure

  Baseline to 3-month follow-up

Study Arms (2)

Heat therapy

EXPERIMENTAL

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.

Device: Leg heat therapy

Sham Control

ACTIVE COMPARATOR

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.

Device: Sham Control

Interventions

Leg heat therapy 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.

Heat therapy

Sham Control 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.

Sham Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Hyperthermia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Central Study Contacts

Kimmy Marshall, RN

CONTACT

317-274-7440; marshki@iu.edu

Bruno Roseguini, Ph.D.

CONTACT

(765) 496-2612; brosegui@purdue.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Surgery

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: November 7, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

US (1)