Metformin's effects on leg pain from poor blood flow
Metformin BenefIts Lower Extremities With Intermittent Claudication (MOBILE_IC)
This study is testing if Metformin can help veterans with leg pain from poor blood flow feel better and improve their walking ability.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 35 Years to 89 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05132439 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Metformin on Veterans suffering from intermittent claudication due to peripheral artery disease (PAD). It is a quadruple-blinded, randomized controlled trial involving 200 participants over three years, where individuals will receive either Metformin or a placebo for six months. The study aims to assess improvements in functional status, reduction in PAD progression, and systemic inflammation. Participants will be monitored for 12 months post-randomization, with additional follow-up for major adverse events over five years.
Who should consider this trial
Good fit: Ideal candidates are male and female Veterans aged 35 to 89 with symptoms of intermittent claudication and documented peripheral artery disease.
Not a fit: Patients with diabetes or those who do not meet the optimal medical therapy criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve walking ability and quality of life for patients with intermittent claudication.
How similar studies have performed: Other studies have shown promise in using Metformin for conditions related to inflammation and blood flow, but this specific application in PAD is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Edith I. Tzeng, MD — VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- Study coordinator: Edith I Tzeng, MD
- Email: Edith.Tzeng@va.gov
- Phone: (412) 360-1657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.