Status:
COMPLETED
A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease
Lead Sponsor:
Purdue University
Collaborating Sponsors:
Aquilo Sports
Conditions:
Peripheral Arterial Disease
Intermittent Claudication
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
The goal of the proposed pilot study is to evaluate the feasibility of a new leg heat therapy system treatment for patients with lower extremity PAD. The new system is comprised of leg-length water ci...
Detailed Description
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 psycho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05335161
Start Date
May 30 2023
End Date
February 7 2024
Last Update
August 15 2025
Active Locations (1)
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1
Purdue University
West Lafayette, Indiana, United States, 47907