Sickle Cell DiseasePhase 2NCT02863068

Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers

A Phase 2 study testing Topical Sodium Nitrite in people with Sickle Cell Disease, run by caterina P minniti at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sickle Cell Disease
What is being tested?: Topical Sodium Nitrite
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 3 sitesUnited States
Study dates: 6 Apr 2018to 24 Nov 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 remover, propellant, fuel additive) Nitrofurantoin (furadantin) Pyridium (phenazopyridine) Phenacetin Phenylhydrazine Rasburicase Sulfonamides (sulfacetamide, sulfamethoxazole, sulfanilamide, sulfapyridine)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Duke University Medical Center
Durham, North Carolina, 27710
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Montefiore Medical Center - Albert Einstein College of Medicine
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: A Phase II Study of Topical Sodium Nitrite in Patients With Sickle Cell and Leg Ulcers

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.

Read the detailed description

Chronic leg ulcers are a complication of many blood disorders such as sickle cell disease, thalassemia, and other red blood cell disorders. In these disorders, red blood cells break down earlier than normal, which researchers suspect may cause or contribute to the development of leg ulcers; however, the exact cause is unknown, and current therapies are not very effective. Researchers are interested in determining if a research cream made with sodium nitrite, a substance that is known to increase blood flow by dilating blood vessels, may speed up the healing of skin ulcers.

Investigators are planning to enroll fifty patients with sickle cell disease to be randomized and treated twice a week with sodium nitrite cream or a placebo for ten weeks. The following events will be compared in treatment and placebo arms: a) changes in blood pressure; b) changes in pulse oximetry; c) changes in methemoglobin levels; d) any adverse events; e) rate of sickle cell disease (SCD) related complications; f) changes in biomarkers of inflammation and other laboratory data such as complete blood count and chemistries.

In order to determine if topical sodium nitrite accelerates wound healing and decreases pain at the wound site compared to placebo in patients receiving similar levels of wound care, investigators will a) accurately measure and photograph ulcers at baseline, after a two week run-in period and at predefined time points during the study and compare treatment arm to placebo; b) pain scores at wound sites will be recorded and compared for the two groups, c) Investigators will calculate opioid intake in the two arms and d) quality of life measures before and at the end of the trial

Conditions: Sickle Cell Disease
Being tested: Topical Sodium Nitrite, Placebo
Keywords: Sickle cell disease, sodium nitrite, wound healing, Ulcer
Medical subject headings: Anemia, Sickle Cell, Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Topical Sodium NitriteDrug
Subjects will have 0.1 cm of 2% sodium nitrite cream applied per 1 cm2 of the total ulcerated area. Areas will be rounded to the nearest 1 cm2. If a subject has more than one ulcer, all of them will be treated with either "study cream" in this intervention.
PlaceboOther
Subjects will have Placebo applied to total ulcerated area. If a subject has more than one ulcer, all of them will be treated with placebo in this intervention.

Study groups in NCT02863068
Study group	Role	What they receive
control	Placebo comparator	patients will receive placebo and standard of care Receives: Other: Placebo
topical sodium nitrite	Experimental	patients will receive 2% topical sodium nitrite cream and standard of care Receives: Drug: Topical Sodium Nitrite

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of Tolerability (Methemoglobin Level)
Assessment of tolerability was determined by evaluating the change in methemoglobin level from baseline through the end of study at week 10. Samples were collected and Methemoglobin levels were measured by co-oximetry Results are summarized by study arm using basic descriptive statistics and expressed as a percentage of the total hemoglobin in the sample.
Measured: Baseline through last available measurement, up to 10 weeks
Change in Total Ulcerated Surface Area
Change in total ulcerated surface area from baseline was assessed through the last study visit at 10 weeks. Surface area measurements of the ulcer were obtained and photographed with defined lighting, distance, exposure, and camera type. Total ulcerated surface area measurements were obtained using digital planimetry and measuring the longest length and widest width of the ulcer(s). Results are summarized by study arm using basic descriptive statistics and reported in cm^2. Negative results are indicative of a reduction in group median total ulcerated surface area from baseline and positive results are indicative of an increase in group median total ulcerated surface area from baseline.
Measured: From Baseline through last study visit at 10 weeks
Change in Ulcer Pain
Change in Ulcer Pain from baseline through the last study visit at 10 weeks were assessed using the Visual Analog Scale (VAS). The VAS is a widely used tool to quantify subjective pain perception over time and in this study was used to determine the efficacy of the topical sodium nitrite. Participants were asked to mark a point on a line indicating the severity of their pain on a 0-10 scale, with "0" representing "No pain" and "10" representing the "Worst possible pain." A decrease in VAS score is indicative of a reduction in ulcer pain. Scores were summarized by study arm using basic descriptive statistics.
Measured: From Baseline through last study visit at 10 weeks
Number of Participants With Total Ulcerated Surface Area Reduction
The number of participants who achieved an objective reduction in total surface area of the ulcer of >= 25% from baseline is summarized and reported as a dichotomous ("No" or "Yes") variable.
Measured: From Baseline through last study visit at 10 weeks

Secondary outcomes (3)

Hydroxyurea Effect on Assessment of Tolerability
Hydroxyurea effect on Assessment of Tolerability, as determined by the change in Methemoglobin level, was conducted to evaluate the effect of hydroxyurea in combination with the topical sodium nitrite or placebo. Samples were collected and Methemoglobin levels were measured by co-oximetry. Study outcomes between participants with use of ("HU") and non-use of ("No HU") hydroxyurea are summarized as an increased or decreased percentage by study arm and analyzed using Wilcoxon-Mann-Whitney statistical testing.
Measured: From Baseline through last study visit at 10 weeks
Hydroxyurea Effect on Change in Total Ulcerated Surface Area
Hydroxyurea effect on Change in Total Ulcerated Surface Area was conducted to evaluate the effect of hydroxyurea in combination with the topical sodium nitrite or placebo. Surface area measurements of the ulcer were obtained and photographed with defined lighting, distance, exposure, and camera type. Total ulcerated surface area measurements were obtained using digital planimetry and measuring the longest length and widest width of the ulcer(s). Study outcomes between participants with use of ("HU") and non-use of ("No HU") hydroxyurea are summarized by study arm as an increase or decrease in total ulcerated surface area in cm^2 and analyzed using Wilcoxon-Mann-Whitney and Fisher Exact statistical testing. Negative results are indicative of a reduction in group median total ulcerated surface area from baseline and positive results are indicative of an increase in group median total ulcerated surface area from baseline (with or without Hydroxyurea).
Measured: From Baseline through last study visit at 10 weeks
Hydroxyurea Effect on Change in Ulcer Pain
Hydroxyurea effect on change in Ulcer Pain was conducted to evaluate the effect of hydroxyurea in combination with the topical sodium nitrite or placebo. Ulcer pain assessments were conducted using the Visual Analog Scale (VAS). The VAS is used to quantify subjective pain perception over time and in this study was used to determine the efficacy of the topical sodium nitrite. Participants were asked to mark a point on a line indicating the severity of their pain on a 0-10 scale, with "0" representing "No pain" and "10" representing the "Worst possible pain." Study outcomes between participants with use of ("HU") and non-use of ("No HU") hydroxyurea are summarized by study arm as an increase or decrease in ulcer pain and analyzed using Wilcoxon-Mann-Whitney statistical testing. Negative results are indicative of a decrease in group median ulcer pain from baseline and positive results are indicative of an increase in group median ulcer pain from baseline (with or without Hydroxyurea).
Measured: From Baseline through last study visit at 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Apr 201824 Nov 2023

First posted11 Aug 2016 (estimated)
Study start6 Apr 2018
Primary completion24 Nov 2023
Study completion24 Nov 2023

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02863068
Sponsor's protocol ID: 2016-6015
Status last verified: May 2025
First submitted: 16 May 2016
Last updated: 7 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Minniti CP, Gorbach AM, Xu D, Hon YY, Delaney KM, Seidel M, Malik N, Peters-Lawrence M, Cantilena C, Nichols JS, Mendelsohn L, Conrey A, Grimes G, Kato GJ. Topical sodium nitrite for chronic leg ulcers in patients with sickle cell anaemia: a phase 1 dose-finding safety and tolerability trial. Lancet Haematol. 2014 Dec 1;1(3):e95-e103. doi: 10.1016/s2352-3026(14)00019-2.
PubMed 25938131

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sickle Cell Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Topical Sodium Nitrite in Patients With Sickle Cell and Leg Ulcers
ClinicalTrials.gov ID: NCT02863068
Acronym / sponsor ID: 2016-6015
Conditions: Sickle Cell Disease
Keywords: Sickle cell disease, sodium nitrite, wound healing, Ulcer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 18 participants (actual)
Lead sponsor: caterina P minnitiUniversity, hospital or other
Collaborators: Duke University
Study start: 6 Apr 2018 (actual)
Primary completion: 24 Nov 2023 (actual)
Study completion: 24 Nov 2023 (actual)
First posted: 11 Aug 2016 (estimated)
Results: Posted 7 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Funding source FDA OOPD.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
control	Placebo comparator	Other: Placebopatients will receive placebo and standard of care
topical sodium nitrite	Experimental	Drug: Topical Sodium Nitritepatients will receive 2% topical sodium nitrite cream and standard of care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Topical Sodium NitriteSubjects will have 0.1 cm of 2% sodium nitrite cream applied per 1 cm2 of the total ulcerated area. Areas will be rounded to the nearest 1 cm2. If a subject has more than one ulcer, all of them will be treated with either "study cream" in this intervention.	Drug	topical sodium nitrite
PlaceboSubjects will have Placebo applied to total ulcerated area. If a subject has more than one ulcer, all of them will be treated with placebo in this intervention.	Other	control

Primary outcome

Assessment of Tolerability (Methemoglobin Level)
Time frame: Baseline through last available measurement, up to 10 weeks
Assessment of tolerability was determined by evaluating the change in methemoglobin level from baseline through the end of study at week 10. Samples were collected and Methemoglobin levels were measured by co-oximetry Results are summarized by study arm using basic descriptive statistics and expressed as a percentage of the total hemoglobin in the sample.
Change in Total Ulcerated Surface Area
Time frame: From Baseline through last study visit at 10 weeks
Change in total ulcerated surface area from baseline was assessed through the last study visit at 10 weeks. Surface area measurements of the ulcer were obtained and photographed with defined lighting, distance, exposure, and camera type. Total ulcerated surface area measurements were obtained using digital planimetry and measuring the longest length and widest width of the ulcer(s). Results are summarized by study arm using basic descriptive statistics and reported in cm^2. Negative results are indicative of a reduction in group median total ulcerated surface area from baseline and positive results are indicative of an increase in group median total ulcerated surface area from baseline.
Change in Ulcer Pain
Time frame: From Baseline through last study visit at 10 weeks
Change in Ulcer Pain from baseline through the last study visit at 10 weeks were assessed using the Visual Analog Scale (VAS). The VAS is a widely used tool to quantify subjective pain perception over time and in this study was used to determine the efficacy of the topical sodium nitrite. Participants were asked to mark a point on a line indicating the severity of their pain on a 0-10 scale, with "0" representing "No pain" and "10" representing the "Worst possible pain." A decrease in VAS score is indicative of a reduction in ulcer pain. Scores were summarized by study arm using basic descriptive statistics.
Number of Participants With Total Ulcerated Surface Area Reduction
Time frame: From Baseline through last study visit at 10 weeks
The number of participants who achieved an objective reduction in total surface area of the ulcer of >= 25% from baseline is summarized and reported as a dichotomous ("No" or "Yes") variable.

3 secondary outcomes

Hydroxyurea Effect on Assessment of Tolerability
Time frame: From Baseline through last study visit at 10 weeks
Hydroxyurea Effect on Change in Total Ulcerated Surface Area
Time frame: From Baseline through last study visit at 10 weeks
Hydroxyurea Effect on Change in Ulcer Pain
Time frame: From Baseline through last study visit at 10 weeks

Results and safety

Results posted to the registry on 7 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	10	10
Topical Sodium Nitrite	8	8

Primary outcome: Assessment of Tolerability (Methemoglobin Level)

Time frame: Baseline through last available measurement, up to 10 weeks. Median (Inter-Quartile Range). Unit: percentage of total hemoglobin

Measure	Placebo n = 10	Topical Sodium Nitrite n = 8
Value	-0.05 (-0.6 to 0.4)	0.25 (-0.3 to 0.4)

Placebo vs Topical Sodium Nitrite: p = 0.2967, Wilcoxon (Mann-Whitney)

Population analysed: For this study, the fundamental analysis unit was the participant and not the ulcer(s). All data is presented accordingly.

Primary outcome: Change in Total Ulcerated Surface Area

Time frame: From Baseline through last study visit at 10 weeks. Median (Inter-Quartile Range). Unit: cm^2

Measure	Placebo n = 10	Topical Sodium Nitrite n = 8
Value	-1.50 (-3.90 to -0.068)	-3.26 (-12.0 to 0.987)

Placebo vs Topical Sodium Nitrite: p = 0.2818, Wilcoxon (Mann-Whitney)
Placebo vs Topical Sodium Nitrite: p = 1.0, Fisher Exact

Population analysed: For this study, the fundamental analysis unit was the participant and not the ulcer(s). All data is presented accordingly.

Primary outcome: Change in Ulcer Pain

Time frame: From Baseline through last study visit at 10 weeks. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Placebo n = 10	Topical Sodium Nitrite n = 8
Value	-0.5 (-2.7 to 1.2)	0.9 (-3.8 to 2.6)

Placebo vs Topical Sodium Nitrite: p = 0.3754, Wilcoxon (Mann-Whitney)

Population analysed: For this study, the fundamental analysis unit was the participant and not the ulcer(s). All data is presented accordingly.

Primary outcome: Number of Participants With Total Ulcerated Surface Area Reduction

Time frame: From Baseline through last study visit at 10 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 10	Topical Sodium Nitrite n = 8
No	5	4
Yes	5	4

Population analysed: For this study, the fundamental analysis unit was the participant and not the ulcer(s). All data is presented accordingly.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 10 (40%)	9 of 10 (90%)	0 of 10
Topical Sodium Nitrite	3 of 8 (37.5%)	4 of 8 (50%)	0 of 8

Limitations and caveats (from the sponsor): Due to the early termination of the study, enrollment in the clinical trial did not reach the target number of participants needed to produce statistically reliable results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25938131Minniti CP, Gorbach AM, Xu D, Hon YY, Delaney KM, Seidel M, Malik N, Peters-Lawrence M, Cantilena C, Nichols JS, Mendelsohn L, Conrey A, Grimes G, Kato GJ. Topical sodium nitrite for chronic leg ulcers in patients with sickle cell anaemia: a phase 1 dose-finding safety and tolerability trial. Lancet Haematol. 2014 Dec 1;1(3):e95-e103. doi: 10.1016/s2352-3026(14)00019-2.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Caterina Minniti, M.D. principal investigator

Montefiore Medical Center

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Topical Sodium Nitrite in people with Sickle Cell Disease, run by caterina P minniti at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Tolerability (Methemoglobin Level) (time frame: Baseline through last available measurement, up to 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02863068, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.