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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: Recruiting Early Phase 1 study of Peripheral Arterial Disease and Peripheral Artery Disease, sponsored by University of Nebraska.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Macrovascular endothelial function will be measured non-invasively using the flow-mediated dilation (FMD) technique in the brachial and popliteal arteries using a Doppler ultrasound. These measures will be performed before and after vumerity or placebo on the first visit, and these measures will be performed before and after Vumerity or placebo on the second visit.
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 |
What NCT06319339 shows while recruiting
NCT06319339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06319339's enrollment target sits among peer trials
20 66th of 79 higher than 12 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial 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.
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