Oxidative-stress-mediated arterial dysfunction in patients with peripheral arterial disease.
L Loffredo, A Marcoccia, P Pignatelli...
https://pubmed.ncbi.nlm.nih.gov/17298965Actively Recruiting
Early Phase 1
Age: 50Years - 75Years
All Genders
Healthy Volunteers
ID06319339
Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease
Led by University of Nebraska · Updated on 2025-10-03
20
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Peripheral artery disease (PAD) affects millions worldwide and involves the narrowing of arteries in the legs and back, leading to muscle pain during exercise and serious complications such as ulcers and gangrene. This study aims to evaluate whether acute intake of diroximel fumarate (Vumerity) can improve antioxidant capacity, reduce oxidative stress, and enhance both vascular function and walking ability in people with PAD. Researchers are testing this by comparing diroximel fumarate with a placebo in participants with PAD and healthy controls. Participants will receive a single dose of either diroximel fumarate or a placebo, followed by the alternate treatment after at least 7 days. The study uses a randomized, double-blind design with crossover between treatments. Vascular and walking function will be assessed using methods such as flow-mediated dilation, arterial stiffness measurement, head-up tilt testing, blood biomarkers, near-infrared spectroscopy, and treadmill walking tests. A follow-up visit will evaluate blood work after diroximel fumarate intake. During the study, participants will undergo assessments before and after each intervention dose on two separate days. These assessments include measures of macrovascular endothelial function, oxygen transfer and use, artery blood flow, and walking capacity. Researchers will monitor blood markers of oxidative stress and antioxidants. The study includes safety monitoring and aims to understand the acute effects of diroximel fumarate on vascular health and physical function in PAD. Total participation time includes initial dosing visits and a follow-up blood evaluation visit.
CONDITIONS
Brief Title
Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease
Who Can Participate
Age: 50Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- Aged between 50 and 75 years
- Diagnosed with Fontaine stage II-III peripheral artery disease or no evidence of peripheral occlusive disease for controls
- History of exercise-induced claudication (PAD participants)
- Females must be postmenopausal (no menses for more than 24 months)
- Normal or stable renal function within the last 6 months
- Normal or stable hepatic function within the last 6 months
- Complete blood count within specified normal ranges or stable counts within the last 6 months
You will not qualify if you...
- Pain at rest or tissue loss due to PAD (Fontaine stage IV)
- Acute lower extremity ischemic event caused by thromboembolic disease or trauma
- Limited walking capacity from other conditions
- No physical exam assessing exercise limitations in the past year
- Currently pregnant or nursing
- Abnormal or unstable renal or hepatic function
- Diagnosis of multiple sclerosis or psoriasis
- Gastrointestinal disorders such as moderate IBS or Crohn's disease
- Use of dimethyl fumarate
- Hypersensitivity to diroximel fumarate or related compounds
- Foot ulcers, gangrene, or necrosis (Fontaine stage IV PAD)
- Complete blood count outside specified normal ranges
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Two treatment days separated by at least 7 days
Participants receive a single dose of either diroximel fumarate or placebo and have vascular function and walking capacity assessed before and after each intervention. After a minimum 7-day washout period, participants receive the alternate intervention with similar assessments.
4 visits (in-person): pre- and post-intervention on Day 1 and Day 7
Follow-up
Duration - Within 1 week after the last intervention
Participants have a follow-up visit to assess blood work after the interventions.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Nebraska - Omaha
Omaha, Nebraska, United States, 68182
Actively Recruiting
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Research Team
S
Song-Young Park, PhD
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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