Actively Recruiting
Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease
Led by University of Nebraska · Updated on 2025-10-03
20
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Age between 50 and 75 years
- Diagnosed with Fontaine stage II-III peripheral artery disease
- History of exercise-induced claudication (leg pain during walking)
- Females must be postmenopausal (no menstrual periods for more than 24 months)
- Normal renal function or stable kidney function in the last 6 months
- Normal liver function or stable liver function in the last 6 months
- Complete blood count within specified normal ranges or stable blood counts in the last 6 months
You will not qualify if you...
- Pain at rest or tissue loss due to PAD (Fontaine stage IV)
- Recent acute lower limb ischemic event from blood clots or trauma
- Walking limitations caused by conditions other than PAD
- No physical exam to assess exercise limitations in the past year
- Currently pregnant or nursing
- Abnormal kidney or liver function based on blood work
- Diagnosis of multiple sclerosis or psoriasis
- Diagnosis of gastrointestinal disorders like moderate IBS or Crohn's disease
- Use of dimethyl fumarate
- Allergy to diroximel fumarate, dimethyl fumarate, or excipients in VUMERITY
- Foot ulcers, gangrene, or necrosis (Fontaine stage IV PAD)
- Complete blood count outside specified normal ranges
- Positive diagnosis of PAD for age-matched control participants
- Limited walking capacity from musculoskeletal injury for controls
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Nebraska - Omaha
Omaha, Nebraska, United States, 68182
Actively Recruiting
Research Team
S
Song-Young Park, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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