TerminatedPhase 2

Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers

Stopped: 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.

United States18 participantsStarted 2018-04-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Glucose-6-Phosphate Dehydrogenase (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 Phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, 4 days prior to screening * Pregnant women - urine or serum Human chorionic gonadotropin (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 remo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of Tolerability (Methemoglobin Level)

Timeframe: Baseline through last available measurement, up to 10 weeks

Change in Total Ulcerated Surface Area

Timeframe: From Baseline through last study visit at 10 weeks

Change in Ulcer Pain

Timeframe: From Baseline through last study visit at 10 weeks

Number of Participants With Total Ulcerated Surface Area Reduction

Timeframe: From Baseline through last study visit at 10 weeks

Trial details

NCT IDNCT02863068

Sponsorcaterina P minniti

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-24

Results submitted2025-02-28

View on ClinicalTrials.gov More Sickle Cell Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Assessment of Tolerability (Methemoglobin Level)

Timeframe: Baseline through last available measurement, up to 10 weeks

Change in Total Ulcerated Surface Area

Timeframe: From Baseline through last study visit at 10 weeks

Change in Ulcer Pain

Timeframe: From Baseline through last study visit at 10 weeks

Number of Participants With Total Ulcerated Surface Area Reduction

Timeframe: From Baseline through last study visit at 10 weeks