← Back to Search

Nitric Oxide Donor

Topical Sodium Nitrite for Leg Ulcers in Sickle Cell Disease

Phase 2
Waitlist Available
Led By Caterina Minniti, M.D.
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have one or more ulcers of the one or both leg or foot
Subjects must have a diagnosis of sickle cell disease (SS, SC, Sß-thalassemia, SD, SOArab)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial will study whether a topical cream containing sodium nitrite can help heal leg ulcers and decrease pain in patients with sickle cell disease. The cream is applied to the ulcer, and possible side effects include decreased blood pressure and methemoglobinemia.

Who is the study for?
This trial is for individuals with sickle cell disease who have leg or foot ulcers. They must not have a history of congenital methemoglobinemia, be pregnant or nursing, and should avoid certain medications that can cause methemoglobinemia. The ulcer's total area for treatment should be no larger than 100 cm2.Check my eligibility
What is being tested?
The study tests a topical cream containing sodium nitrite against a placebo to see if it speeds up healing and reduces pain in leg ulcers associated with sickle cell disease. It's a Phase II study where the safety and effectiveness of the cream are being evaluated.See study design
What are the potential side effects?
Possible side effects from the sodium nitrite cream include lowered blood pressure and methemoglobinemia, which is an abnormal amount of methemoglobin in the blood potentially caused by absorption through ulcerated skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have one or more open sores on your leg or foot.
Select...
You have been diagnosed with sickle cell disease.
Select...
The total size of the leg ulcer(s) that will be treated must be no bigger than 100 square centimeters.
Select...
You don't have a condition called congenital methemoglobinemia since birth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of tolerability
Ulcer pain reduction
Ulcer size reduction
Secondary outcome measures
Hydroxyurea Effect

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: topical sodium nitriteExperimental Treatment1 Intervention
patients will receive 2% topical sodium nitrite cream and standard of care
Group II: controlPlacebo Group1 Intervention
patients will receive placebo and standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical Sodium Nitrite
2018
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,580 Total Patients Enrolled
Montefiore Medical CenterLead Sponsor
440 Previous Clinical Trials
581,585 Total Patients Enrolled
Duke UniversityOTHER
2,351 Previous Clinical Trials
3,409,520 Total Patients Enrolled

Media Library

Sickle Cell Disease Research Study Groups: control, topical sodium nitrite

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the community engaging with this research?

"Affirmative. Clinicaltrials.gov evidences that this clinical trial, which was initially advertised on April 6th 2018, is currently recruiting participants. 50 individuals are expected to be enrolled from 2 separate research centres."

Answered by AI

Could you elucidate on the potential hazards of Topical Sodium Nitrite?

"Our evaluation of Topical Sodium Nitrite's safety stands at 2, due to the lack of clinical data demonstrating its efficacy yet some evidence pointing towards its basic level of security."

Answered by AI

Is this experiment presently open to new participants?

"The data hosted on clinicaltrials.gov indicates that this medical research is actively seeking participants. The study was initially advertised on April 6th, 2018 and the most recent update to its listing occurred on April 5th 2022."

Answered by AI

Is this a pioneering trial, or have similar ones been conducted before?

"Research into Topical Sodium Nitrite began in 2016, with Mast Therapeutics Inc. sponsoring the inaugural clinical trial of 35 participants. Following its Phase 1 & 2 approval, there are currently 4 active studies related to this substance being conducted across two cities and one nation."

Answered by AI

What prior investigations have been conducted concerning the application of Topical Sodium Nitrite?

"Sodium Nitrite was first studied in 2016 at Children's Hospital of Pittsburgh. 18,341 past trials have been concluded and there are currently 4 active experiments being conducted mostly in the city of Pittsburgh."

Answered by AI
~4 spots leftby Mar 2025