MetfOrmin BenefIts Lower Extremities With Intermittent Claudication

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Nov 12, 2021

Keywords

ClinConnect Summary

The MOBILE IC Trial is studying whether Metformin, a medication usually used to treat Type 2 diabetes, can help improve walking ability and quality of life for Veterans suffering from intermittent claudication due to peripheral arterial disease (PAD). Intermittent claudication causes pain in the legs when walking because of reduced blood flow, and currently, there are no effective medical treatments for this condition. The researchers hope that Metformin, which has been shown to reduce inflammation and improve blood flow, can be a safe and effective option for these patients.

To participate in the trial, Veterans aged between 35 and 89 with symptoms of intermittent claudication may be eligible if they are medically stable and have been following specific medical therapies for at least three months. Participants will complete walking tests and may receive either Metformin or a placebo (a sugar pill that looks like the medication but has no active ingredients) to see how it affects their ability to walk and their overall health. This trial is an important step towards finding better treatments for those living with PAD and intermittent claudication, and it provides a unique opportunity for eligible Veterans to contribute to this research.

Gender

ALL

Eligibility criteria

• 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