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NCT05465070 · ClinicalTrials.gov registry record · NA
Leg Heat Therapy in Peripheral Artery Disease
A NA study of Peripheral Artery Disease, sponsored by Indiana University.
- Recruiting
- Registry status
- NA
- Development phase
- 106
- Enrollment target
- 1
- Study location
NCT05465070: Recruiting NA study of Peripheral Artery Disease, sponsored by Indiana University.
NCT05465070 is a NA study of Peripheral Artery Disease that is actively recruiting participants, run by Indiana University. The registered enrollment target is 106 participants, below the 125-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05465070, a NA study of Peripheral Artery Disease, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from lower-extremity peripheral artery disease (PAD). We will randomize 106 patients to one of two groups that either receive leg HT or a sham intervention. The primary study outcome is the change in 6-minute walk distance between baseline and the 12-week follow up. Secondary outcomes include changes in the short physical performance battery score, handgrip strength, quality of life (measured by the Walking Impairment Questionnaire and Short-Form (SF)-36 Questionnaire), calf muscle strength (measured using a calf ergometer), size (measured by magnetic resonance imaging) and bioenergetics (assessed using phosphorus-31 magnetic resonance spectroscopy), and physical activity (measured by accelerometer).
Primary Outcome
The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the 6-minute walk distance at 3-month follow-up compared to a sham treatment.
Conditions Studied
Interventions
- DEVICE Sham Control
- DEVICE Leg heat therapy
Study Locations (1)
Indiana
- Indiana University Health Methodist Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2022-11-07 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT05465070 shows while recruiting
NCT05465070 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 125-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Peripheral Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Sham Control is the first listed.
NCT05465070 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05465070 about?
NCT05465070 is a clinical study titled "Leg Heat Therapy in Peripheral Artery Disease". The goal of this randomized, double-blind, sham-controlled clinical trial is to evaluate the benefits of home-based, leg heat therapy (HT) on lower-extremity functioning and quality of life in patients who suffer from lower-extremity peripheral artery disease (PAD). We will randomize 106 patients to...
What is the current status of trial NCT05465070?
This trial is currently recruiting. It is a NA study. The enrollment target is 106 participants. The study started on 2022-11-07. Estimated completion is 2026-12-31.
What conditions does trial NCT05465070 study?
This clinical trial studies the following conditions: Peripheral Artery Disease.
What interventions are being tested in trial NCT05465070?
The interventions under investigation include: Sham Control (DEVICE), Leg heat therapy (DEVICE).
Who is sponsoring clinical trial NCT05465070?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05465070 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05465070's enrollment target sits among peer trials
106 23rd of 50 higher than 28 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease 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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