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Metformin for Intermittent Claudication

This study is investigating if Metformin ER, a medication commonly used for Type 2 diabetes, can help improve walking ability in people with intermittent claudication (IC). IC is muscle pain in the legs that happens during activity due to poor blood flow, often caused by peripheral arterial disease (PAD). Currently, there isn't an effective medical treatment for IC. Researchers believe Metformin ER might help by reducing inflammation and improving blood flow. The study aims to enroll 200 participants, aged 35 to 89, who are veterans with IC and are medically stable. The main goal is to see how much a person's maximal walking distance improves after 6 months of treatment. The study is currently recruiting, but its overall status is unclear.

Study design
This is a quadruple-blinded randomized controlled trial, meaning neither you nor the study team will know if you are receiving Metformin ER or a placebo. It plans to enroll 200 participants.
What's involved
Your active involvement will last for 12 months, including study visits and phone calls. After this, the study team will review your medical charts for 5 years.
Compensation
Not stated in the trial record.
Follow-up
You will be observed and monitored for 12 months after starting the study drug. The study team will then review your medical charts for 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05132439

MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

Recruiting
PHASE3Ages 35–89InterventionalTreatment
VA Office of Research and Development
~200 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Metformin ERplacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximal Walking distance on the 6 minute walk test
Measured over 6 month

Conditions

Intermittent Claudication

Explore related trials

Intermittent claudicationPeripheral Artery Disease

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Edith I. Tzeng, MD · PRINCIPAL_INVESTIGATOR · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Who to contact

Edith I Tzeng, MD
[email protected]
(412) 360-1657
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
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

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

What this trial measures

  • Maximal Walking distance on the 6 minute walk test6 month

    This validated measure of functional status in PAD and IC is highly reproducible and the ideal measure of real-life walking capacity