Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
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.