Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06480760
Eligibility Criteria:
Inclusion Criteria:
1. Participants between 40-80 years of age.
2. White or African American race.
3. Literate in English.
4. ABI \>0.4-\<0.90, obtained within 6 weeks from enrollment.
5. Willing and able to comply with protocol requirements.
6. Participant is able to provide informed consent.
Exclusion Criteria:
1. 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.
2. Critical limb ischemia with below or above the knee amputations or any form of foot ulceration over the symptomatic leg.
3. Presence of significant injury within 30 days, or vascular intervention on the symptomatic leg within 6 months before enrollment, as per physician's discretion.
4. Participants with a baseline 6MWT of less than 152.0 meters (498ft) or greater than 487.7 meters (1600ft).
5. Known allergy to L-carnosine.
6. Participants with rare autosomal recessive metabolic disorder carnosinemia or carnosinase deficiency.
7. Currently participating in other clinical trials.
8. Participation in any carnosine supplementation clinical trial anytime in the past.
9. Participants already taking carnosine.
10. Participants unable to provide urine sample (anuric).
11. Pregnant participants.
12. Participants using dual antiplatelet therapies will not be included for biopsy.
13. Participants with internal metallic objects in body will not be eligible for MRI or 1HMRS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06480760
Study Brief:
Protocol Section:
NCT06480760