NCT05132439 MetfOrmin BenefIts Lower Extremities With Intermittent Claudication
| NCT ID | NCT05132439 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | VA Office of Research and Development |
| Condition | Intermittent Claudication |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2022-03-01 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. Those with PAD and IC experience a progressive decline in walking and poor quality of life. There is no effective medical treatment for PAD and IC. Metformin is a safe and effective treatment for Type 2 diabetes but it can also reduce inflammation, oxidative stress, and improve energy requirements as well as improve blood flow to the legs. Therefore, the investigators will test the ability of Metformin to improve overall functional status, reduce PAD progression, and reduce systemic inflammation in Veterans suffering from PAD and IC in a randomized, placebo controlled trial: Metformin BenefIts Lower Extremities with Intermittent Claudication (MOBILE IC) Trial. The success of this trial may identify a safe and effective treatment for PAD and IC.
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
Contact & Investigator
Edith I. Tzeng, MD
PRINCIPAL INVESTIGATOR
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Frequently Asked Questions
Who can join the NCT05132439 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 89 Years, studying Intermittent Claudication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05132439 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT05132439 currently recruiting?
Yes, NCT05132439 is actively recruiting participants. Contact the research team at Edith.Tzeng@va.gov for enrollment information.
Where is the NCT05132439 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05132439 clinical trial?
NCT05132439 is sponsored by VA Office of Research and Development. The principal investigator is Edith I. Tzeng, MD at VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA. The trial plans to enroll 200 participants.