Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers
Summary
The investigators are conducting a Phase II prospective and placebo controlled study 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.
Timeline
- Start
- 2018-04-06
- Primary completion
- 2023-11-24
- Completion
- 2023-11-24
Outcome
Missed primary endpoint
Stopped (Enrollment): “Study terminated prior to achieving target enrollment due to slow recruitment and high cost of obtaining new study drug. Since no additional funds were to be available due to end of the funding period, remaining funds were expended on analyses.”
registry analysis (superiority test); Placebo vs Topical Sodium Nitrite; p = 0.2967; Wilcoxon (Mann-Whitney) NCT02863068 ↗
registry analysis (superiority test); Placebo vs Topical Sodium Nitrite; p = 0.2818; Wilcoxon (Mann-Whitney) NCT02863068 ↗
registry analysis (superiority test); Placebo vs Topical Sodium Nitrite; p = 0.3754; Wilcoxon (Mann-Whitney) NCT02863068 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Nitrite | Small molecule | 2 % | Topical |