Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Collaborator: Food and Drug Administration (FDA)

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 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 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)