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Behavioural Intervention

Leg Heat Therapy for Peripheral Arterial Disease

N/A

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Men and women older than 60 years

Be older than 18 years old

Must not have

Prior foot or leg amputation

Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3-month follow-up

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for men and women over 60 with lower-extremity peripheral artery disease (PAD), evidenced by a low ankle-brachial index. It's not for those with critical limb ischemia, other conditions limiting exercise tolerance, recent leg surgeries, use of walking aids besides a cane, severe kidney disease or obesity, inability to wear water-circulating trousers, certain mental impairments or thermal sensation issues in the legs.

What is being tested?

The study tests if home-based leg heat therapy improves walking ability and quality of life in PAD patients compared to a sham control. Participants are randomly assigned to either real heat treatment or fake (sham) intervention and followed up after 12 weeks to measure changes in walk distance and various health scores.

What are the potential side effects?

Potential side effects may include discomfort from the heat application or skin irritation under the water-circulating trousers used for therapy. Since it's non-invasive, serious side effects are unlikely but monitoring will occur for any unexpected reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 60 years.

Exclusion Criteria

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

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I have had a foot or leg amputation.

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I have severe leg pain at rest or wounds that won't heal due to poor blood flow.

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My kidney function is severely reduced.

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I use a walking aid that is not a cane.

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I can't have an MRI due to certain medical devices or conditions.

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My BMI is 35 or higher.

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I cannot fit into water-circulating trousers.

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My cancer is currently active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in 6-minute walk distance

Secondary study objectives

Change in Short Physical Performance Battery (SPPB) score

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

Change in Walking Impairment Questionnaire (WIQ) score

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Heat therapyExperimental Treatment1 Intervention

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.

Group II: Sham ControlActive Control1 Intervention

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.

0 / 9Eligibility criteria met