MetfOrmin BenefIts Lower Extremities With Intermittent Claudication (MOBILE IC)
Intermittent Claudication
About this trial
This is an interventional treatment trial for Intermittent Claudication focused on measuring Peripheral artery disease, intermittent claudication, metformin, anti-inflammatory agents, clinical trial protocol, atherosclerosis
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
Sites / Locations
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PARecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Metformin ER 1000mg
Matching placebo
daily by mouth
daily by mouth