Using Carnosine to Improve Function in Patients with Peripheral Arterial Disease

Carnosine for Peripheral Arterial Disease Patients (Car-PAD)

This study is testing if taking L-carnosine as a supplement can help people with Peripheral Arterial Disease walk better and improve their quality of life.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 50 Years to 80 Years
• Sex: Male
• Sponsor: University of Louisville (other)
• Locations: 1 site (Louisville, Kentucky)
• Trial ID: NCT05371145 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of oral L-carnosine supplementation on patients with Peripheral Arterial Disease (PAD). The study aims to increase muscle carnosine levels, stabilize HIF1-alpha, and promote angiogenesis to enhance lower extremity function. Participants will be monitored for improvements in walking ability and overall quality of life. The trial includes both Phase 1 and Phase 2 assessments to evaluate safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates are English-speaking male patients aged 50 to 80 with an ankle-brachial index between 0.4 and 0.6.

Not a fit: Patients with critical limb ischemia, significant comorbidities, or those who have undergone major amputations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve mobility and quality of life for patients suffering from PAD.

How similar studies have performed: While the approach of using carnosine is novel in this context, previous studies have shown potential benefits of carnosine supplementation in other conditions, suggesting a promising avenue for PAD treatment.

Eligibility criteria

Inclusion Criteria:

1. Male subjects more than \>50 to \<80 years of age.
2. White or African American race.
3. English Speaking.
4. ABI 0.4-\< 0.60
5. Willing to comply with protocol requirements.
6. Able to provide informed consent. -

Exclusion Criteria:

1. Subjects with HIV, hepatitis, significant liver disease, active infection, anemia, organ transplant, renal disease requiring dialysis, lung disease requiring oxygen, significant congenital heart disease, cancer of any type, and untreated thyroid disease.
2. Diagnosis of carnosinemia.
3. Known allergy to L-carnosine or meat.
4. Presence of a pacemaker.
5. Obesity from a known genetic defect.
6. Dementia.
7. Critical limb ischemia with below or above knee amputations.
8. Foot ulcers.
9. Major amputations.
10. Participating in other clinical trials.
11. End stage renal disease.
12. Presence of significant injury within 30 days before enrollment.
13. Prisoners.
14. Any metallic implants.
15. Poorly controlled diabetes (HbA1C \>9%) -

Where this trial is running

Louisville, Kentucky

• University of Louisville — Louisville, Kentucky, United States (RECRUITING)

Conditions: Peripheral Arterial Disease