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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05465070
The ClinicalTrials.gov registry entry for NCT05465070 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 125-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (15% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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