Improve PAD PERformance With METformin (NCT03054519) | Clinical Trial Compass
CompletedPhase 3
Improve PAD PERformance With METformin
United States203 participantsStarted 2017-05-23
Plain-language summary
The PERMET trial will determine whether metformin daily for six months improves six-minute walk performance in individuals with peripheral artery disease compared to placebo.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All participants will have PAD. PAD will be defined as follows:
* First, an ankle brachial index (ABI) \<=0.90 at the baseline study visit is an inclusion criterion for PAD.
* Second, potential participants who have an ABI \> 0.90 but ≤ 1.00 and experience a 20% or higher drop in ABI after heel-rise exercise will be eligible.
* Third, potential participants with an ABI \> 0.90 who have vascular lab evidence of PAD or angiographic evidence of PAD who have ischemic symptoms during the six-minute walk and/or treadmill exercise stress test will be eligible.
* Fourth, potential participants with a history of lower extremity revascularization who do not meet the criterion above and have an ABI \> 0.90 with a 20% or higher drop in ABI after heel-rise exercise will be eligible.
Exclusion Criteria:
* Above- or below-knee amputation.
* Critical limb ischemia.
* Wheelchair-bound or requiring a walker to ambulate.
* Walking is limited by a symptom other than PAD.
* Current foot ulcer on bottom of foot.
* Diabetes mellitus defined as one or more of a) patient report of physician diagnosed diabetes mellitus, b) use of one or more diabetes medications, c) two baseline hemoglobinA1C values of \>6.5, d) two fasting glucose values \>126 mg/dl. \[NOTE: the second fasting glucose value and hemoglobin A1C values will be at the discretion of the principal investigator. For example, if the first glucose value is \>300 or the first A1C value is \>6.9, then investigators may d…
What they're measuring
1
Six-minute walk performance
Timeframe: Change from baseline to six-month follow-up