Status:
COMPLETED
Carnosine for Peripheral Arterial Disease
Lead Sponsor:
University of Louisville
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
The hypothesis is that oral supplementation of L-carnosine will inhibit PHDs, increase HIF1-translocation and angiogenesis and thus improve the functioning of lower extremities in PAD patients. Prima...
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
- Subjects between 50 and 80 years of age.
- English Speaking.
- ABI 0.3 -\<0.90 (in at least one leg).
- Willing to comply with protocol requirements.
- Able to provide informed consent.
- Able to walk on a treadmill for more than 2 minutes -
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.
- 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
- Poorly controlled diabetes (HbA1C \>9%).
- Able to walk for more than 12 minutes.
- Currently taking Pletal (cilostazol) or Trentol (pentoxifylline) -
Key Trial Info
Start Date :
May 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04870229
Start Date
May 12 2016
End Date
July 1 2022
Last Update
August 4 2022
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202