Metformin's effects on leg pain from poor blood flow

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Exercise therapy for people with leg pain from poor circulation in Denmark

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.