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RECRUITING

NCT06319339

EARLY_PHASE1

Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease

Sponsor: University of Nebraska

View on ClinicalTrials.gov

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.

Official title: Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-11-14

Completion Date

2026-08

Last Updated

2025-10-03

Healthy Volunteers

Yes

Conditions

Peripheral Artery Disease Peripheral Vascular Diseases Peripheral Arterial Disease Peripheral Arterial Occlusive Disease

Interventions

DRUG

Vumerity

diroximal fumarate 462 mg (2 capsules)

OTHER

Placebo

Microcrystalline cellulose 462 mg (2 capsules)

Inclusion Criteria: 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 * Complete blood count: * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L, or evidence of stable blood counts within the last 6 months * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L, or evidence of stable blood counts within the last 6 months Age-matched control participants: * Able to provide written informed consent * 50-75 years of age * No evidence of peripheral occlusive disease (ankle-brachial index \> 0.90) * 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 * Complete blood count: * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count \> 700 million lymphocytes/L, or evidence of stable blood counts within the last 6 months Exclusion Criteria: 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) * Normal hepatic function (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L), * Diagnosis of multiple sclerosis or psoriasis * Diagnosis of gastrointestinal disorders (e.g., moderate IBS, Crohn's disease, etc. * Concomitant use of dimethyl fumarate * Hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY * Ulcers, gangrene, or necrosis of the foot (Fontaine stage IV PAD) * Complete blood count NOT within ranges: * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L Age-matched control participants: * Positive diagnosis of PAD * No physical exam to assess exercise limitations in the past year * Any exercise limitations as determined at last physical exam * Limited walking capacity from musculoskeletal injury * Currently pregnant or nursing * Renal function not within normal ranges (serum creatinine-estimated glomerular filtration rate \>\> 60 mL/min) * Hepatic function not within normal ranges (alanine transaminase 0-35 IU/L, alkaline phosphatase 30-120 IU/L, total bilirubin 2-17 micromoles/L) * Complete blood count NOT within ranges: * Females: red blood cell 4-5 trillion cells/L, hemoglobin 12-15 g/dL, hematocrit 34-45%, white blood cell count 3-10 billion cells/L, platelet count 160-380 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L * Males: red blood cell 4-6 trillion cells/L, hemoglobin 13-17 g/dL, hematocrit 38-49%, white blood cell count 3-10 billion cells/L, platelet count 135-320 billion/L, and normal lymphocyte count 1-4.8 billion lymphocytes/L

Locations (1)

University of Nebraska - Omaha

Omaha, Nebraska, United States