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NCT05543980 · ClinicalTrials.gov registry record · Phase 1
Leg Heat Therapy in Elderly Individuals
A Phase 1 study, sponsored by Purdue University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT05543980: Completed Phase 1 study, sponsored by Purdue University.
NCT05543980 is a Phase 1 study that has completed, run by Purdue University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05543980, a Phase 1 study, has completed, sponsored by Purdue University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This pilot randomized, sham-controlled trial aimed to establish the feasibility and safety of home-based leg HT in community-dwelling older adults and inform the design of a future, larger study. Participants were randomized to either an HT or a sham group and were asked to apply the treatment daily for 90 min over 12 consecutive weeks. The primary outcomes were compliance with the HT regimen, measured by a hidden timer, completion rates, and device safety. The secondary goals were to examine the effects of leg HT on 6-min walk distance, sit-to-stand performance, blood pressure, quality of life, and the morphology and strength of the calf muscles, as assessed using combined T1-weighted and mDixon magnetic resonance imaging (MRI). Building upon previous findings in young individuals, preclinical models of PAD, and older individuals with PAD, we hypothesized that older adults treated with leg HT for 12 weeks would display improved walking performance, increased calf strength, and reduced intramuscular fat when compared to sham-treated individuals.
Primary Outcome
A built-in timer inside the pump that is inaccessible to participants will provide one assessment of patient compliance with the therapy. Compliance will be determined by dividing the number of hours of HT recorded use by the required hours. In addition, patients in both groups will receive a logbook to record their treatment sessions.
Interventions
- DEVICE Sham device
- DEVICE Leg heat therapy device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-09-05 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 1 |
What the finished NCT05543980 record still lists
NCT05543980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham device is the first listed.
NCT05543980 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05543980 about?
NCT05543980 is a clinical study titled "Leg Heat Therapy in Elderly Individuals". This pilot randomized, sham-controlled trial aimed to establish the feasibility and safety of home-based leg HT in community-dwelling older adults and inform the design of a future, larger study. Participants were randomized to either an HT or a sham group and were asked to apply the treatment daily...
What is the current status of trial NCT05543980?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-09-05. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT05543980?
The interventions under investigation include: Sham device (DEVICE), Leg heat therapy device (DEVICE).
Who is sponsoring clinical trial NCT05543980?
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 NCT05543980's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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