MetfOrmin BenefIts Lower Extremities With Intermittent Claudication
Status:
Not yet recruiting
Trial end date:
2029-12-15
Target enrollment:
Participant gender:
Summary
Peripheral arterial disease (PAD) affects over 20% of aged adults and is very common among
Veterans due significant tobacco use. PAD is due to the progressive blockage of peripheral
arteries, predominantly to the legs, and results in intermittent claudication (IC) or
recurrent muscle pain with activity secondary to insufficient blood supply. Those with PAD
and IC experience a progressive decline in walking and poor quality of life. There is no
effective medical treatment for PAD and IC. Metformin is a safe and effective treatment for
Type 2 diabetes but it can also reduce inflammation, oxidative stress, and improve energy
requirements as well as improve blood flow to the legs. Therefore, the investigators will
test the ability of Metformin to improve overall functional status, reduce PAD progression,
and reduce systemic inflammation in Veterans suffering from PAD and IC in a randomized,
placebo controlled trial: Metformin BenefIts Lower Extremities with Intermittent Claudication
(MOBILE IC) Trial. The success of this trial may identify a safe and effective treatment for
PAD and IC.
Phase:
Phase 3
Details
Lead Sponsor:
VA Office of Research and Development
Collaborators:
Northwestern University San Francisco Veterans Affairs Medical Center University of Pittsburgh