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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT02553733
Eligibility Criteria:
Inclusion Criteria:
1. Patients with peripheral arterial disease (PAD)
2. Capable of giving informed consent
3. Men and women age 21- 85 years
4. Diagnosed with PAD (i.e., ankle-brachial index below 0.9)
5. Fontaine stage II or less - no pain while resting
6. Satisfactory history and physical exam
Exclusion Criteria:
1. Children
2. Pregnant or nursing women
3. Patients taking nitroglycerine or nitrate preparations
4. Patients taking phosphodiesterase inhibitors such as sildenafil or tadalafil
5. Patients taking proton pump inhibitors
6. Ejection fraction \< 40%
7. Uncontrolled hypertension
8. Uncontrolled diabetes
9. Myocardial infarction within past 6 months or unstable angina
10. Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers)
11. Abnormality in hemoglobin or hematocrit or methemoglobin
12. Impaired renal function
13. Impaired liver function
14. History or diagnosis of Barrett's esophagus
15. Known allergy to beetroot juice or lemon juice
16. Inability to walk on a treadmill at a moderate pace (2.0 miles/hour)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT02553733
Study Brief:
Protocol Section:
NCT02553733