A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease
Completed · Phase 1
Conditions studied: Peripheral Arterial Disease, Intermittent Claudication
In brief
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 circulating pads surrounded by a separate pneumatic compression outer garment that compresses the pads against the skin for efficient heat transfer. The new leg garment is easily closed with a zipper. The air chambers automatically adjust the amount of air inflation enabling use of the garment independent of patient leg size. Six patients with PAD will be asked to complete daily (90 min/day) home-based leg HT for 12 weeks using the newly developed system. The primary study outcome is the change from baseline in walking performance on the 6-minute walk test at the 12-week follow-up. Secondary outcomes include plantar flexion power, as assessed using isokinetic dynamometry, sit-to-stand muscle power and perceived quality of life.
Key facts
- Study ID
- NCT05335161
- Run by
- Purdue University
- People needed
- 6
- Starts
- 2023-05-30
- Expected to finish
- 2024-02-07
- Last updated by the study team
- 2025-08-15
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Purdue University — West Lafayette, Indiana, United States
Full record on ClinicalTrials.gov
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