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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT02863068
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have a diagnosis of sickle cell disease (SS, SC, Sß-thalassemia, SD, SOArab)
* Have one or more ulcers of the one or both leg or foot
* Total surface area of leg ulcer(s) that will receive treatment must be no larger than 100 cm2
* No history of congenital methemoglobinemia
* Have documented normal Glucose-6-Phosphate Dehydrogenase (G6PD) activity
Exclusion Criteria:
* Exposure to therapeutic nitric oxide, L-arginine, nitroprusside or nitroglycerine within the past 1 week
* Subjects presenting with clinically diagnosed bacterial infection (e.g., osteomyelitis, pneumonia, sepsis or meningitis)
* Subjects who have a pre-existing methemoglobinemia (more than 3.5% on two different occasions)
* Patients who are currently enrolled in any other investigational drug study (this does not include observational or natural history protocols)
* Use of Phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, 4 days prior to screening
* Pregnant women - urine or serum Human chorionic gonadotropin (hCG)+ or nursing mothers
* The following list of drugs and agents may cause methemoglobinemia and should be avoided while on this study:
Anesthetics (local): Benzocaine, procaine, prilocaine, Anbesol, Orajel Antimalarials: chloroquine, primaquine, quinacrine Aniline dyes Chlorates Dapsone Diarylsulfonylureas Doxorubicin Metoclopramide Nitric and nitrous oxide Nitrobenzenes (shoe and floor polish and in paint solvents) Nitroethane (artificial nail remover, propellant, fuel additive) Nitrofurantoin (furadantin) Pyridium (phenazopyridine) Phenacetin Phenylhydrazine Rasburicase Sulfonamides (sulfacetamide, sulfamethoxazole, sulfanilamide, sulfapyridine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02863068
Study Brief:
Protocol Section:
NCT02863068