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NCT05335161 · ClinicalTrials.gov registry record · Phase 1
A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease
A Phase 1 study, sponsored by Purdue University.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT05335161: Completed Phase 1 study, sponsored by Purdue University.
NCT05335161 is a Phase 1 study that has completed, run by Purdue University. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05335161, a Phase 1 study, has completed, sponsored by Purdue University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Primary Outcome
Participants will receive standardized instructions and will be asked to walk the greatest distance possible by walking back and forth along a 100-ft corridor for 6 min.
Interventions
- DEVICE Home-based leg heat therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2023-05-30 |
| Est. Completion | 2024-02-07 |
| Phase | Phase 1 |
What the finished NCT05335161 record still lists
NCT05335161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Home-based leg heat therapy is the first listed.
NCT05335161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05335161 about?
NCT05335161 is a clinical study titled "A New Heat Therapy Device for Home-based Leg Heating in Patients With Lower-extremity Peripheral Artery Disease". 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...
What is the current status of trial NCT05335161?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2023-05-30. Estimated completion is 2024-02-07.
What interventions are being tested in trial NCT05335161?
The interventions under investigation include: Home-based leg heat therapy (DEVICE).
Who is sponsoring clinical trial NCT05335161?
This trial is sponsored by Purdue University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05335161's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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