Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease
Eligible age
50–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: University of Nebraska
You may qualify if…
- ✓ Peripheral artery disease (PAD) participants:
- ✓ Able to provide written informed consent
- ✓ 50-75 years of age
- ✓ Diagnosed as Fontaine stage II-III
- ✓ History of exercise-induced claudication
- ✓ Females must be postmenopausal (cessation of menses for \> 24 months)
- ✓ Normal renal function (serum creatinine-estimated glomerular filtration rate \>= 60 mL/min) or evidence of stable renal function within the last 6 months
- ✓ Normal hepatic function (alanine transaminase \< 87.5 U/L, alkaline phosphatase \< 260 U/L, total bilirubin 1.8 mg/dL) or evidence of stable hepatic function within the last 6 months
You may not qualify if…
- ✕ Peripheral artery disease (PAD) participants:
- ✕ • Pain at rest and/or tissue loss due to PAD (Fontaine stage IV PAD)
- ✕ Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
- ✕ Limited walking capacity from conditions other than PAD
- ✕ No physical exam to assess exercise limitations in the past year
- ✕ Currently pregnant or nursing
- ✕ Blood work and medical history NOT demonstrating:
- ✕ Normal renal function (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min)
Where it's recruiting
Omaha
Source: ClinicalTrials.gov · NCT06319339 · last updated 2026-06-24