A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease

Launched by PURDUE UNIVERSITY · Apr 13, 2022

Keywords

ClinConnect Summary

Lower-extremity PAD is a manifestation of systemic atherosclerosis associated with increased risk of cardiovascular morbidity and mortality, diminished quality of life, physical functioning and psychological well-being. In 2015, an estimated 236 million people worldwide, most between 65 and 69 years of age, were living with PAD. Home-based leg heat therapy (HT) is emerging as a potential effective and practical treatment to increase leg blood flow and improve walking performance in patients with symptomatic PAD. In the first randomized sham-controlled trial to examine the benefits of superv...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women 60 years or older
• • Resting ankle-brachial index (ABI) of 0.9 or less in at least one leg.
• • Individuals with a resting ABI between 0.91 and 1.00 at baseline will be eligible if their ABI drops by 20% or greater following a heel-rise test.
• Exclusion Criteria:
• • Critical limb ischemia (ischemic rest pain or ischemia-related, non-healing wounds or tissue loss)
• • Prior amputation
• • Exercise tolerance limited by factors other than leg pain (e.g. angina, arthritis, severe lung disease, etc).
• • Recent (\<3 months) lower-extremity revascularization or orthopedic surgery
• • Use of walking aid other than a cane
• • Active cancer
• • Chronic kidney disease (eGFR \<30 by MDRD or Mayo or Cockcroft-Gault formula)
• • Unable to fit into water-circulating trousers
• • A Mini-Mental Status Examination score \<23
• • Impaired thermal sensation in the leg
• • Age lower than 60 yrs