MedTrace Logo

Home-Based Lower-Extremity Heat Therapy for Walking Function in Peripheral Artery Disease

NCT07653243 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-17

No results posted yet for this study

Summary

Lower-extremity peripheral artery disease is associated with impaired walking ability, reduced lower-extremity function, and decreased quality of life. This randomized, sham-controlled clinical trial will evaluate the effects of 12 weeks of home-based lower-extremity heat therapy on walking function and mobility in adults with peripheral artery disease.

A total of 40 participants will be randomized to active lower-extremity heat therapy or sham therapy. Participants assigned to active therapy will complete daily 90-minute home treatment sessions using heated lower-extremity garments. Participants assigned to sham therapy will complete the same treatment schedule using a lower-temperature sham condition.

The primary outcome is the change in six-minute walk distance from baseline to 12 weeks. Secondary outcomes include changes in leg strength and fatigability, Short Physical Performance Battery score, blood pressure, and patient-reported quality of life.

Conditions

  • PAD
  • PAD - Peripheral Arterial Disease

Interventions

DEVICE

Lower-Extremity Heat Therapy

Participants assigned to the active intervention will complete home-based lower-extremity heat therapy sessions for 90 minutes per day for 12 weeks. The active condition will deliver heated therapy to the lower extremities according to the study protocol.

DEVICE

Sham Lower-Extremity Heat Therapy

Participants assigned to the sham comparator will complete home-based sham therapy sessions for 90 minutes per day for 12 weeks. The sham condition will use the same treatment schedule and similar lower-extremity garments as the active condition, but will use a lower-temperature condition intended to support participant blinding while minimizing the expected physiological effects of active heat therapy.

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • Purdue University

    collaborator OTHER

  • Aquilo Sports, LLC

    lead INDUSTRY

Principal Investigators

  • Raghu Motaganahalli, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2029-03-30
Completion
2029-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07653243 on ClinicalTrials.gov