Actively Recruiting
MetfOrmin BenefIts Lower Extremities With Intermittent Claudication
Led by VA Office of Research and Development · Updated on 2026-04-21
200
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
U
University of Pittsburgh
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MetfOrmin BenefIts Lower Extremities With Intermittent Claudication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female Veterans aged over 35 and under 89 years
- Symptoms of intermittent claudication
- Medically stable and on optimal medical therapy for at least 3 months prior to randomization (including statins, anti-platelet therapy, blood pressure control, smoking cessation, and physical activity counseling)
- Peripheral arterial disease confirmed by ankle-brachial index less than 0.9 or pulse volume recordings within 6 months prior to randomization
- Ability to walk at least 50 meters with pain onset before or at 400 meters during a 6-minute walk test without using a walker (cane allowed) within 6 months prior to randomization
You will not qualify if you...
- Diagnosis of Type 1 or Type 2 diabetes or Hemoglobin A1c over 6.5 within 6 months prior to randomization
- Currently taking Metformin or have taken it within the last 6 months
- Medical conditions limiting ability to walk other than PAD (such as angina, congestive heart failure, pulmonary disease requiring oxygen, or active cancer treatment)
- Prior above or below knee amputation
- Critical limb threatening ischemia (non-healing wounds or rest pain)
- Planned hospitalization, major surgery, or lower extremity revascularization within 12 months after randomization
- Major surgery or lower extremity revascularization within 3 months before randomization
- Inability to complete quality of life testing due to non-English speaking or dementia
- Kidney disease requiring dialysis or estimated glomerular filtration rate below 45 within 6 months prior to randomization
- Planned iodinated contrast imaging within 6 months prior to randomization
- Current or history of liver failure
- Pregnant or breastfeeding women
- Unable to swallow uncrushed pills
- Investigator believes participation may cause harm to the participant
AI-Screening
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Trial Site Locations
Total: 1 location
1
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Actively Recruiting
Research Team
E
Edith I Tzeng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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