Phase 1
N=6
A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease
Peripheral Arterial Disease · Intermittent Claudication
Bottom Line
View on ClinicalTrials.gov: NCT05335161 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Six-minute Walk Distance — 32.3 Meters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Home-based leg heat therapy (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Purdue University
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Six-minute Walk Distance |
32.3 | — |
| SECONDARY Change in Walking Impairment Questionnaire Score |
11.08 | — |
| SECONDARY Device Usability Using the System Usability Scale |
49 | — |
| SECONDARY Change in Triceps Surae Peak Torque |
4.49 | — |
| SECONDARY Change in the Five Times Sit to Stand Test |
-1.93 | — |
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 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.
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
Data sourced from ClinicalTrials.gov (NCT05335161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.