|Caterina Minniti, M.D.|
2 United States sites
> 18 Years
– Subjects must have a diagnosis of sickle cell disease (SS, SC, Sß-thalassemia, SD,
– 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
– No history of congenital methemoglobinemia.
– Have documented normal G6PD activity.
– 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
– Patients who are currently enrolled in any other investigational drug study (this does
not include observational or natural history protocols).
– Use of PDE5 inhibitors, such as sildenafil, 4 days prior to screening.
– Pregnant women (urine or serum 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)