A Phase II Study of Topical Sodium Nitrite in Patients With Sickle Cell and Leg Ulcers

Study point of contact

Caterina Minniti, M.D.
718-920-4180
[email protected]

Locations

2 United States sites

Age

> 18 Years

Genotypes

SC

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

Other

Compensation

Unknown

About the study

The investigators propose a Phase II study, prospective and placebo controlled, of a topical
cream containing sodium nitrite compared to the current standard of care. Sodium nitrite is a
local donor of nitric oxide, which is known to improve blood flow and decrease bacterial load
in the ulcer bed. The primary objectives are to evaluate the safety of topical sodium nitrite
cream treatment in patients with sickle cell disease and chronic leg ulcers and to determine
its effectiveness in accelerating the healing process and decreasing the pain associated with
ulceration.

Potential benefit will be a durable resolution or improvement of the leg ulcer and its
associated pain. Possible side effects include decreased blood pressure and
methemoglobinemia, secondary to sodium nitrite absorption through the ulcerated skin. Funding
source FDA OOPD.

participation requirements

– 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 G6PD activity.

participation restrictions

– 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 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)

Locations

  • Bronx, New York, United States, Montefiore Medical center, 10467 [Recruiting]
  • Pittsburgh, Pennsylvania, United States, University Of Pittsburgh, 15261 [Recruiting]