Heat therapy for Peripheral Arterial Disease

Phase-Based Progress Estimates
Indiana University Health Methodist Hospital, Indianapolis, INPeripheral Arterial DiseaseLeg heat therapy - Device
All Sexes
What conditions do you have?

Study Summary

This trial will evaluate the effects of leg heat therapy on lower-extremity functioning and quality of life in patients with PAD. 106 patients will be randomized to either leg HT or a sham intervention. Outcomes will be monitored for 12 weeks.

Eligible Conditions
  • Peripheral Arterial Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline to 3-month follow-up

Baseline to 3-month follow-up
Change in 6-minute walk distance
Change in Short Physical Performance Battery (SPPB) score
Change in Short-Form (SF)-36 Questionnaire score
Change in Walking Impairment Questionnaire (WIQ) score
Diastolic blood pressure
Change in handgrip strength
Change in systolic blood pressure
Change in the time constant for phosphocreatine recovery after dynamic exercise
Change in triceps surae intramuscular fat content
Change in triceps surae volume

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Sham Control
1 of 2
Heat therapy
1 of 2

Active Control

Experimental Treatment

106 Total Participants · 2 Treatment Groups

Primary Treatment: Heat therapy · No Placebo Group · Phase 3

Heat therapy
Experimental Group · 1 Intervention: Leg heat therapy · Intervention Types: Device
Sham Control
ActiveComparator Group · 1 Intervention: Sham Control · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 3-month follow-up

Who is running the clinical trial?

Purdue UniversityOTHER
212 Previous Clinical Trials
63,699 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
7 Patients Enrolled for Peripheral Arterial Disease
Indiana UniversityLead Sponsor
896 Previous Clinical Trials
770,443 Total Patients Enrolled
6 Trials studying Peripheral Arterial Disease
111 Patients Enrolled for Peripheral Arterial Disease

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a device called a cardiac defibrillator implanted in your heart.
You have a device implanted in your body to stimulate your nerves.
You have a device implanted in your body that delivers medication.
You have a heart pacemaker.
You have aneurysm clips in your body.
You have a device called a carotid artery vascular clamp.
You are using a device that helps bones grow or fuse together.
You have a cochlear implant, ear implant or other hearing device.
You use insulin or an infusion pump.

Frequently Asked Questions

What detrimental effects does Heat therapy pose to individuals?

"Our assessment of Heat therapy's safety is 3 out of 3, as the trial has reached Phase three and there is ample evidence for both its efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Are there still vacancies in this research trial for participants?

"This clinical trial, posted on November 11th 2022, is actively seeking participants. It was last revised on February 27th 2023 according to information on clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer

Is there a predetermined quota of participants for this research endeavor?

"Affirmative. The clinicaltrials.gov website reveals that this research is still open for enrollment, having been posted on November 11th 2022 and most recently updated in February 27th 2023. 106 patients are required to participate at a single site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.