Status:
RECRUITING
Carnosine for Peripheral Arterial Disease Patients
Lead Sponsor:
Shahid Baba
Conditions:
Peripheral Arterial Disease
Eligibility:
MALE
50-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Oral supplementation of L-carnosine will increase muscle carnosine, stabilize HIF1-alpha promote angiogenesis, and thus improve the functioning of lower extremities in PAD patients.
Detailed Description
Peripheral arterial disease (PAD) is caused by atherosclerotic occlusion of the lower extremities that reduces blood flow and leads to intermittent claudication and critical limb ischemia. PAD is diag...
Eligibility Criteria
Inclusion
- Male subjects more than \>50 to \<80 years of age.
- White or African American race.
- English Speaking.
- ABI 0.4-\< 0.60
- Willing to comply with protocol requirements.
- Able to provide informed consent. -
Exclusion
- 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.
- Diagnosis of carnosinemia.
- Known allergy to L-carnosine or meat.
- Presence of a pacemaker.
- Obesity from a known genetic defect.
- Dementia.
- Critical limb ischemia with below or above knee amputations.
- Foot ulcers.
- Major amputations.
- Participating in other clinical trials.
- End stage renal disease.
- Presence of significant injury within 30 days before enrollment.
- Prisoners.
- Any metallic implants.
- Poorly controlled diabetes (HbA1C \>9%) -
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05371145
Start Date
March 1 2023
End Date
December 30 2024
Last Update
July 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Louisville
Louisville, Kentucky, United States, 40202