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New treatment option for Peripheral Arterial Disease
Official title Effects of Carnosine In Patients With Peripheral Arterial Disease Patients
ClinicalTrials.gov ID: NCT06480760
What this study is testing
What is Carnosine?
Carnosine is an investigational medicine, being studied as a potential treatment for peripheral arterial disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine whether carnosine (a food ingredient found in chicken and red meat) supplementation (2 g) for 6 months in participants with non-claudication and claudication peripheral arterial disease (PAD) improves walking ability. Previous studies with heart failure patients have shown that carnosine supplementation increases walking capacity in these patients.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Participants between 40-80 years of age.
- White or African American race.
- Literate in English.
- ABI \>0.4-\<0.90, obtained within 6 weeks from enrollment.
- Willing and able to comply with protocol requirements.
You likely can't join if
- As per physician's discretion, participants with HIV, hepatitis, significant liver disease, anemia, renal disease requiring dialysis, lung disease...
- Critical limb ischemia with below or above the knee amputations or any form of foot ulceration over the symptomatic leg.
- Presence of significant injury within 30 days, or vascular intervention on the symptomatic leg within 6 months before enrollment, as per physician's...
- Participants with a baseline 6MWT of less than 152.0 meters (498ft) or greater than 487.7 meters (1600ft).
- Known allergy to L-carnosine.
- Participants with rare autosomal recessive metabolic disorder carnosinemia or carnosinase deficiency.
See the full eligibility criteria
- Participants between 40-80 years of age.
- White or African American race.
- Literate in English.
- ABI \>0.4-\<0.90, obtained within 6 weeks from enrollment.
- Willing and able to comply with protocol requirements.
- Participant is able to provide informed consent.
- As per physician's discretion, participants with HIV, hepatitis, significant liver disease, anemia, renal disease requiring dialysis, lung disease requiring home oxygen therapy, and active cancer may be excluded.
- Critical limb ischemia with below or above the knee amputations or any form of foot ulceration over the symptomatic leg.
- Presence of significant injury within 30 days, or vascular intervention on the symptomatic leg within 6 months before enrollment, as per physician's discretion.
- Participants with a baseline 6MWT of less than 152.0 meters (498ft) or greater than 487.7 meters (1600ft).
- Known allergy to L-carnosine.
- Participants with rare autosomal recessive metabolic disorder carnosinemia or carnosinase deficiency.
- Currently participating in other clinical trials.
- Participation in any carnosine supplementation clinical trial anytime in the past.
- Participants already taking carnosine.
- Participants unable to provide urine sample (anuric).
- Pregnant participants.
- Participants using dual antiplatelet therapies will not be included for biopsy.
- Participants with internal metallic objects in body will not be eligible for MRI or 1HMRS.
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.