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:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT03240068
Eligibility Criteria:
Inclusion Criteria:
* Sex: Male or Female
* Age: 21-80 years of age
* Diagnosed with PAD (e.g. ankle-brachial index below 0.9)
* Fontaine stage II or less (no rest pain)
* Capable of giving informed consent
* Fluent in written and spoken English
Exclusion Criteria:
* Age less than or equal to 20 years or greater than or equal to 81 years
* Pregnant or nursing woman
* Decisional impairment
* Prisoners
* Alcohol or drug abuse
* Evidence of type I or type II diabetes (fasting glucose \>126 mg/dl or use of anti-diabetic medications)
* History of serious cardiovascular disease (e.g. myocardial infarction within 6 months, symptomatic coronary artery disease, presence of angina pectoris, significant arrhythmia, congestive heart failure, deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, hypertrophic cardiomyopathy) or cerebrovascular disease (e.g. cerebral hemorrhage, stroke, transient ischemic attack).
* History or presence of immunological or hematological disease
* Impaired hepatic function \[aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \> 2 times the upper limit of normal range)
* Impaired renal function (serum creatinine \>2.0 mg/dl)
* Anemia
* Treatment with serotonin-norepinephrine reuptake inhibitors (SNRI) or norepinephrine transporter (NET) inhibitors
* Treatment with phosphodiesterase-5 inhibitors
* Treatment with anticoagulants
* Treatment with chronic systemic glucocorticoid therapy (\>7 consecutive days in 1 month)
* Treatment with any investigational drug in the 1-month preceding the study
* Inability to give, or withdraw, informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT03240068
Study Brief:
Protocol Section:
NCT03240068