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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT05893160
Eligibility Criteria:
Inclusion Criteria:
* Male and female individuals aged 18-70
* Ambulatory with knee pain for greater than 6 months prior to surgery, and willing and able to comply with all study requirements will be considered eligible.
Exclusion Criteria:
* Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 120 mmHg);
* BMI greater than 45 kg/m2;
* Active smoker or stopped smoking within 6 months of enrollment;
* Active local or systemic malignancy, such as lung cancer or leukemia;
* Cardiovascular disease resulting in dyspnea at rest;
* Peripheral neurovascular disease;
* Anemia;
* Hematological disease (eg, coagulopathy, sickle cell disease/anemia);
* Hemoglobin variant;
* Glucose-6-phosphate dehydrogenase deficiency;
* Methemoglobin reductase deficiency;
* Known sensitivity to nitrites;
* Liver disease;
* Use of phosphodiesterase type 5 inhibitors;
* Use of sildenafil (Viagra);
* Systemic treatment with antibiotics, immunosuppressants including corticosteroids, medications for migraine, allopurinol, tricyclic antidepressants, antihistamines, and/or nitrates currently or in the last month;
* Use of nitrovasodilators (e.g. GTN) within the last month;
* Use of protein pump inhibitors within the last month;
* History of substance abuse;
* Recent surgery or hospitalization (within last 6 months);
* Inability to swallow a pill;
* Failure to provide full consent;
* Involvement with a worker's compensation, personal injury, or other legal matter related to participant health.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05893160
Study Brief:
Protocol Section:
NCT05893160