Evaluating the Effects of Diroximel Fumarate on Blood Vessel and Leg Function and Walking Ability in Adults Aged 50 to 75 with Peripheral Artery Disease

What this Trial Is About

Peripheral artery disease PAD affects many people worldwide and involves narrowed arteries in the legs and back, causing muscle pain during exercise and serious complications like ulcers and amputation. This study aims to see if taking a drug called diroximel fumarate Vumerity can improve blood vessel function and walking ability by reducing oxidative stress, which is believed to worsen PAD. Researchers will assess how this drug affects blood flow and muscle function in individuals with PAD compared to a placebo. Participants will receive a single dose of diroximel fumarate or a matching placebo, then after at least seven days, they will switch to the other treatment in a randomized crossover design. The study evaluates the immediate effects of diroximel fumarate on vascular function and walking capacity. Tests include measuring artery dilation, stiffness, blood flow, muscle oxygen use, and walking ability on a treadmill. A follow-up visit will check blood markers several days after treatment. During the study, participants undergo various assessments such as flow-mediated dilation tests, arterial stiffness measurements, blood biomarker collection, near-infrared spectroscopy, and a treadmill walking test both before and after each treatment. The main outcomes measured are blood vessel function, oxygen use, blood flow, and walking capacity. Safety and antioxidant blood markers will also be monitored. The study includes adults aged 50 to 75 and spans approximately two visits with a washout period between treatments.

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