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New treatment option for Intermittent Claudication
Official title MetfOrmin BenefIts Lower Extremities With Intermittent Claudication
ClinicalTrials.gov ID: NCT05132439
What this study is testing
What is Metformin ER?
Metformin ER is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for intermittent claudication.
Also referred to as Glucophage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 89
You may be able to join if
- 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...
- PAD as defined by ABI \ 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...
You likely can't join if
- 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...
- 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)
See the full eligibility 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...
- PAD as defined by ABI \ 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.