Could a common diabetes drug ease leg pain for millions?
NCT ID NCT05132439
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether metformin, a standard diabetes drug, can improve walking ability in people with peripheral artery disease (PAD) who experience leg pain during activity. Researchers will give 200 Veterans either metformin or a placebo for several months and measure changes in walking distance. The goal is to find a safe, effective treatment for a condition that currently has few options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin (extended-release)
- What this could lead to
- If it works, this could provide a safe, affordable treatment to help people with PAD walk farther and have less leg pain.
- What could go wrong
- This is still an early-stage test in a specific group (Veterans), and metformin may not improve walking more than a placebo. Side effects like stomach upset are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Feb 2032
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 89 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
RECRUITINGPittsburgh, Pennsylvania, 15240, United States
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