Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers
Public ClinicalTrials.gov record NCT02863068. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study of Topical Sodium Nitrite in Patients With Sickle Cell and Leg Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02863068
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 18 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 6, 2018 (Actual)
- Primary completion
- Nov 24, 2023 (Actual)
- Completion
- Nov 24, 2023 (Actual)
- Last update posted
- May 7, 2025
2018 – 2023
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Montefiore Medical Center - Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02863068, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 7, 2025 · Synced Oct 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02863068 live on ClinicalTrials.gov.