NCT05132439 · VA Office of Research and Development
MetfOrmin BenefIts Lower Extremities With Intermittent Claudication
(MOBILE IC)
What this study 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.
View original scientific description
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.
Interventions
DRUG
Metformin ER
Oral medication typically used for Type 2 diabetes with presumed anti-inflammatory properties
DRUG
placebo
Matched to active study drug
Primary outcome measures
Maximal Walking distance on the 6 minute walk test
Time frame: 6 month
This validated measure of functional status in PAD and IC is highly reproducible and the ideal measure of real-life walking capacity
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and Female Veteran \>35 \& \<89
- Symptoms of Intermittent claudication
- Medically stable, optimal medical therapy (for \>3 months prior to randomization which includes - statin and anti-platelet therapy, blood pressure control, smoking cessation and physical activity counseling) a. Participants may not comply with the above measures to meet inclusion criteria, but investigator driven attempts to maximize the optimal medical therapy, as tolerated, for each participant prior to trial enrollment
- PAD as defined by ABI \<0.9 or \>0.9 with evidence of PAD as documented by pulse volume recordings (within 6 months prior to expected randomization date)
- Maximum Walking Distance (MWD) on the 6-minute walk test (6MWT) of greater than or equal to 50 meters with onset of pain before or at 400 meters without the use of a walker (cane is acceptable; within 6 months of expected randomization date)
Exclusion criteria
- Diabetes (Type I or II) or Hemoglobin A1c\>6.5 (within 6 months of expected randomization)
- Currently Taking metformin or have previously taken metformin (within 6 months of enrollment)
- Medical condition that limit their ability to ambulate other than PAD (i.e., Angina, CHF, pulmonary disease requiring oxygen, malignancy requiring treatment, etc.)
- Prior above or below knee amputation
- Critical limb threatening ischemia (i.e., non-healing wounds or rest pain)
- Planned hospital admission, major operation, or lower extremity revascularization to be completed (within 12 months after expected randomization date)
- Prior major operation or lower extremity revascularization (within the 3 months before expected randomization)
- Unable to complete quality of life testing due to Non-English Speaking and/or Dementia
- Kidney disease - dialysis or eGFR\<45 (within 6 months of expected randomization date)\
- Planned iodinated contrasted study (within 6 months of expected randomization date)
- Evidence current or history of hepatic failure
- Women who are pregnant or breast feeding
- Unable to swallow uncrushed pills
- Investigator expects inclusion could cause harm to subject
Where
- Pittsburgh, Pennsylvania
Collaborators
University of Pittsburgh, Northwestern University, San Francisco Veterans Affairs Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations