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Anti-diabetic agent
Metformin for Peripheral Arterial Disease (PERMET Trial)
Phase 3
Recruiting
Led By Mary McDermott, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with a history of lower extremity revascularization and ABI > 0.90 with a 20% or higher drop in ABI after heel-rise exercise
Participants with PAD defined as ABI <=0.90 at the baseline study visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to six-month follow-up
Awards & highlights
PERMET Trial Summary
This trial will test whether metformin can improve walking performance in people with peripheral artery disease.
Who is the study for?
This trial is for individuals with Peripheral Arterial Disease (PAD). Eligible participants may have had lower extremity revascularization, an Ankle-Brachial Index (ABI) of ≤0.90, or a significant drop in ABI after exercise indicating PAD. Exclusions include those planning major surgeries, with severe illnesses like advanced cancer or lung disease requiring oxygen, dementia, recent heart issues, non-English speakers, amputations above/below the knee, wheelchair users or walker dependence.Check my eligibility
What is being tested?
The PERMET trial is testing if taking metformin daily for six months can improve walking performance over a six-minute period compared to a placebo in people with PAD. Participants will be randomly assigned to either receive metformin or a placebo and their walking ability will be measured.See study design
What are the potential side effects?
Metformin may cause side effects such as digestive upset including nausea and diarrhea; it might also affect blood sugar levels leading to hypoglycemia especially in diabetic patients not included in this study.
PERMET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery to improve blood flow in my legs and my ankle-brachial index drops significantly after exercise.
Select...
My ankle-brachial index (ABI) is 0.90 or lower.
Select...
I have leg artery disease with symptoms during physical tests.
PERMET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to six-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to six-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Six-minute walk performance
Secondary outcome measures
Brachial artery flow-mediated dilation
Calf muscle biopsy biochemical measures
Maximal treadmill walking time
+2 morePERMET Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: MetforminActive Control1 Intervention
Metformin daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo daily for six months.
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,019 Total Patients Enrolled
24 Trials studying Peripheral Arterial Disease
4,210 Patients Enrolled for Peripheral Arterial Disease
Mary McDermott, MD5.01 ReviewsPrincipal Investigator - Northwestern University
Northwestern University
11 Previous Clinical Trials
1,672 Total Patients Enrolled
11 Trials studying Peripheral Arterial Disease
1,672 Patients Enrolled for Peripheral Arterial Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery to improve blood flow in my legs and my ankle-brachial index drops significantly after exercise.I have a current ulcer on the bottom of my foot.I am currently taking or have taken metformin in the last six months.I do not speak English.My vision problems make it hard for me to walk.My ankle-brachial index (ABI) is 0.90 or lower.Your ankle-brachial index (ABI) is between 0.90 and 1.00, and it drops by 20% or more after doing a specific exercise.I have had an amputation above or below the knee.I haven't had major surgery or a significant heart event in the last 3 months.I do not have major illnesses like severe kidney, lung disease, Parkinson's, or any life-threatening condition expected to shorten my life to less than six months.My chest pain has gotten worse or I have chest pain even when resting.I use a wheelchair or walker to move around.I have been diagnosed with chronic kidney disease.I have severe blockage in my leg arteries causing pain and ulcers.My walking is limited due to a reason other than peripheral artery disease.I have a long-term liver condition.I have been diagnosed with diabetes.I am scheduled for major surgery, like leg surgery, in the next 6 months.You have difficulty with memory and thinking, or have been diagnosed with dementia.You did not finish the 2-week study introduction period successfully.I have leg artery disease with symptoms during physical tests.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other scientific studies have included Metformin as a variable?
"There are currently 180 clinical trials being conducted to study metformin. 45 of those are in the last stage before FDA approval. Most of these studies originate out of Pittsburgh, Pennsylvania; however, there 1952 total locations running trials for this drug."
Answered by AI
To what extent is this study's sample size adequate?
"That is correct. The table on clinicaltrials.gov affirms that this study, which was originally posted on May 1st 2017, has open recruitment and is looking for 212 participants across 3 differentSite locations."
Answered by AI
Metformin is frequently prescribed for which condition?
"Metformin is a medication with many potential applications, including exercise-induced anaerobic metabolism and the treatment of type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."
Answered by AI
Has the Food and Drug Administration cleared Metformin for public consumption?
"There is prior clinical data supporting Metformin's safety, so it received a score of 3."
Answered by AI
Can new participants join this research project?
"That is correct. The listing on clinicaltrials.gov currently states that the trial is open for recruitment. This study was originally posted on May 1st, 2017 and last updated on November 14th, 2022. A total of 212 individuals are needed across 3 different research sites."
Answered by AI
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