Home-based Leg Heat Therapy

NCT03763331 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-03-01

Study results available
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Summary

The objective of this study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (HT) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Control/Sham Treatment

Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.

DEVICE

Heat Therapy

Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.

Sponsors & Collaborators

  • Roseguini, Bruno, PhD

    collaborator INDIV
  • Indiana University

    lead OTHER

Principal Investigators

  • R Motaganahalli · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2021-06-21
Completion
2021-06-21
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03763331 on ClinicalTrials.gov