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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
Must not have
Current foot ulcer on bottom of foot
Non-English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to six-month follow-up
Awards & highlights
Summary
This trial will test if taking metformin daily can help people with peripheral artery disease walk better by improving their blood flow and reducing inflammation. Metformin has been studied for its potential benefits in improving endothelial function and reducing inflammation in various conditions, including type 2 diabetes and 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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a current ulcer on the bottom of my foot.
Select...
I do not speak English.
Select...
My vision problems make it hard for me to walk.
Select...
I have had an amputation above or below the knee.
Select...
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.
Select...
My chest pain has gotten worse or I have chest pain even when resting.
Select...
I use a wheelchair or walker to move around.
Select...
I have been diagnosed with chronic kidney disease.
Select...
I have severe blockage in my leg arteries causing pain and ulcers.
Select...
My walking is limited due to a reason other than peripheral artery disease.
Select...
I have a long-term liver condition.
Select...
I have been diagnosed with diabetes.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Six-minute walk performance
Secondary study objectives
Brachial artery flow-mediated dilation
Calf muscle biopsy biochemical measures
Maximal treadmill walking time
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: MetforminActive Control1 Intervention
Metformin daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo daily for six months.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peripheral Arterial Disease (PAD) treatments aim to improve blood flow and reduce symptoms such as claudication. Common treatments include exercise therapy, which enhances muscle efficiency and circulation, and pharmacologic therapies like statins and cilostazol.
Statins lower cholesterol, reducing plaque buildup in arteries, while cilostazol improves blood flow by inhibiting platelet aggregation and dilating blood vessels. Metformin, being studied in the PERMET trial, may improve endothelial function and reduce inflammation, potentially enhancing walking performance in PAD patients.
These mechanisms are crucial as they address the underlying vascular issues and improve quality of life.
Molecular mechanisms of vascular dysfunction and cardiovascular biomarkers in type 2 diabetes.
Molecular mechanisms of vascular dysfunction and cardiovascular biomarkers in type 2 diabetes.
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,630 Previous Clinical Trials
956,073 Total Patients Enrolled
26 Trials studying Peripheral Arterial Disease
4,276 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
Media Library
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.
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