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Heating Treatments for Peripheral Artery Disease (EPR Trial)

Phase < 1

Recruiting

Led By Jian Cui

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with PAD (i.e., ankle-brachial index below 0.9)

Capable of giving informed consent

Must not have

Decisional impairment

History of CAD with symptoms of unstable angina or myocardial infarction (<6 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit.

Summary

This trial will study how heat exposure affects blood pressure and the sympathetic nervous system in patients with peripheral artery disease.

Who is the study for?

This trial is for men and women aged 21-85 with Peripheral Artery Disease (PAD), specifically those who can consent, speak English, have an ankle-brachial index below 0.9 without rest pain, and are generally healthy otherwise. It excludes pregnant or nursing women, individuals under 21 or with decisional impairments, prisoners, and those with other chronic diseases or recent severe cardiac events.

What is being tested?

The study tests if heating methods like a heating suit or warm water immersion before exercise can reduce the sympathetic nervous system's response in PAD patients. The hypothesis suggests that heat may make muscle receptors less sensitive to stress from exercise.

What are the potential side effects?

Potential side effects might include discomfort due to heat exposure such as sweating or overheating during the use of heating suits or baths. There could also be skin irritation from prolonged contact with warm water.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with peripheral artery disease (PAD).

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I understand the study and can agree to participate.

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I don't have pain in my legs while resting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty making decisions due to a mental condition.

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I have had heart issues like unstable angina or a heart attack in the last 6 months.

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I have a chronic condition like heart, lung, muscle disease, or diabetes.

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I am younger than 21 years old.

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I have a history of epilepsy or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood pressure in mmHg

Heart Rate in beats per minute

Walking time in minutes

Secondary study objectives

Thermography

Near infrared spectroscopy (NIRS) in arbitrary units

Trial Design

10Treatment groups

Experimental Treatment

Placebo Group

Group I: PAD warm bathExperimental Treatment2 Interventions

Subjects will take a warm bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.

Group II: PAD lower limb warm water immersionExperimental Treatment2 Interventions

Subjects will place their lower legs in warm water. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.

Group III: PAD heating suitExperimental Treatment2 Interventions

Whole body heating with the suit will be performed. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.

Group IV: Healthy subjects warm bathExperimental Treatment2 Interventions

Group V: Healthy subjects lower limb immersionExperimental Treatment2 Interventions

Group VI: Healthy subjects heat suitExperimental Treatment2 Interventions

Group VII: Healthy subjects without heatingPlacebo Group2 Interventions

Subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.

Group VIII: Healthy subjects neutral bathPlacebo Group2 Interventions

Subjects will take a neutral bath. Then, subjects will walk on a treadmill using the Gardner protocol until the patient says they want to stop. BP, HR and NIRS will be continuously measured during Gardner protocol. Skin blood flow, skin temperature and BP will be measured in the supine position before and after the Gardner protocol.

Group IX: PAD without heatingPlacebo Group2 Interventions

Group X: PAD neutral bathPlacebo Group2 Interventions

0 / 8Eligibility criteria met