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NCT06319339 · ClinicalTrials.gov registry record · Early Phase 1
Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease
A Early Phase 1 study of Peripheral Arterial Disease and Peripheral Artery Disease, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06319339 is a Early Phase 1 study of Peripheral Arterial Disease and Peripheral Artery Disease that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 20 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06319339, a Early Phase 1 study of Peripheral Arterial Disease and Peripheral Artery Disease, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. There will be a follow-up visit to assess blood work after diroximel fumarate.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Vumerity
Study Locations (1)
Nebraska
- University of Nebraska - Omaha - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-11-14 |
| Est. Completion | 2026-08 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06319339
The ClinicalTrials.gov registry entry for NCT06319339 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06319339 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT06319339 about?
NCT06319339 is a clinical study titled "Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease". Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exer...
What is the current status of trial NCT06319339?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2024-11-14. Estimated completion is 2026-08.
What conditions does trial NCT06319339 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Peripheral Artery Disease, Peripheral Vascular Diseases, Peripheral Arterial Occlusive Disease.
What interventions are being tested in trial NCT06319339?
The interventions under investigation include: Placebo (OTHER), Vumerity (DRUG).
Who is sponsoring clinical trial NCT06319339?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06319339 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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