Home heat therapy for walking problems in peripheral artery disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults older than 50 years with peripheral artery disease, a narrowing of the leg arteries. It tests 12 weeks of daily heat therapy at home using heated leg garments.

Age

Older than 50 years

Sex

Men and women

Disease stage

Peripheral artery disease with a resting ankle-brachial index (ABI) of <0.9 but >0.4 in at least one leg. People with critical limb ischemia cannot join.

Earlier treatment

People who had lower-extremity revascularization (a procedure to restore leg blood flow) or orthopedic surgery in the last 3 months cannot join. People with a prior amputation cannot join.

Biomarker or test result

Resting ankle-brachial index (ABI) of <0.9 but >0.4 in at least one leg.

Main reasons for not taking part

• Critical limb ischemia: leg pain at rest, or wounds or tissue loss that do not heal
• Prior amputation, or using a walking aid other than a cane
• Another illness that limits exercise, or active treatment for cancer
• Chronic kidney disease with eGFR <30
• Class 2 or 3 obesity (BMI ≥ 35 kg/m2), or unable to fit into water-circulating trousers

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Active Lower-Extremity Heat TherapyTreatment being tested

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

  Treatment: Lower-Extremity Heat Therapy

• Sham Lower-Extremity Heat TherapySham treatment, for comparison

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