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Dipeptide
Carnosine for Peripheral Arterial Disease (CAR-PAD Trial)
Phase 1 & 2
Recruiting
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
CAR-PAD Trial Summary
This trial suggests that L-carnosine supplements can improve the symptoms of peripheral artery disease.
Who is the study for?
This trial is for men aged 50-80 with Peripheral Arterial Disease, having an ABI of 0.4 to less than 0.60, and who can follow the study rules. They must be White or African American, speak English, and give informed consent. It's not for those with severe diseases like HIV or cancer, carnosinemia, allergies to L-carnosine/meat, pacemakers/metal implants, recent major injuries/amputations/ulcers or uncontrolled diabetes.Check my eligibility
What is being tested?
The trial tests if taking L-carnosine pills helps improve leg function in PAD patients by increasing muscle carnosine levels and promoting new blood vessel growth.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include allergic reactions to L-carnosine or issues related to increased muscle carnosine levels.
CAR-PAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Carnosine for Peripheral Arterial Disease patients
Secondary outcome measures
Graded treadmill test
Side effects data
From 2012 Phase 2 trial • 33 Patients • NCT008103688%
Hypergammaglobulinemia
8%
Costochondritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carnosine Treatment Group
Placebo Control Group
CAR-PAD Trial Design
1Treatment groups
Experimental Treatment
Group I: Carnosine intervention for patients with PADExperimental Treatment1 Intervention
This is a single arm open labelled safety trial, where we will supplement carnosine for 3 months to subjects with non-claudication and claudication peripheral arterial disease (PAD), and determine if it improves walking ability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carnosine
Not yet FDA approved
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
339 Previous Clinical Trials
76,660 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
10 Patients Enrolled for Peripheral Arterial Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have HIV, hepatitis, severe liver disease, active infection, anemia, organ transplant, kidney disease needing dialysis, lung disease needing oxygen, serious heart disease from birth, any type of cancer, or untreated thyroid disease.You have been diagnosed with carnosinemia.You are allergic to L-carnosine or meat.You have a pacemaker.You have obesity caused by a known genetic problem.You have dementia.You have severe blockage in the blood vessels of your leg, and have had an amputation below or above the knee.You have ulcers on your feet.You have had a major limb removed.You have severe kidney disease.You have any metal implants in your body.Your ankle-brachial index (ABI) is between 0.4 and less than 0.60.You had a major injury within the last 30 days before joining the study.Your diabetes is not well controlled, with a high HbA1C level above 9%.Men between 50 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Carnosine intervention for patients with PAD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there vacancies available for individuals to participate in this scientific experiment?
"Per clinicaltrials.gov, this trial has concluded its recruitment phase; initial posting occuring on December 1st 2022 and the last update being November 16th 2022. While there are no longer any openings for this particular research project, 217 other trials remain active and in search of participants."
Answered by AI
Are any elderly individuals eligible for inclusion in this trial?
"The minimum age requirement for this trial is 50 and the maximum cap on participants' ages is 80, as set by established inclusion criteria."
Answered by AI
What demographic is eligible to partake in this research study?
"This research is seeking 20 individuals with peripheral arterial disease, aged 50 to 80. Crucially, participants must possess the following qualifications: White or African American ethnicity., Speak English fluently., Ankle-Brachial Index (ABI) ranging from 0.4 - <0.60., Receptive to comply with protocol specifications., Capable of providing informed consent.. , Male subjects whose age falls within >50 and <80 years old.."
Answered by AI
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