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

Phase 1

Completed

• Conditions: Peripheral Arterial Disease; Intermittent Claudication

• Registration Number: NCT05335161
• Lead Sponsor: Purdue University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-4-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six-minute walk distance

Secondary Outcome Measures

Name	Time	Method
Walking Impairment Questionnaire;Device usability using the System Usability Scale;Triceps surae power output;Sit-to-stand (STS) muscle power