Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    50
  • sponsor
    Montefiore Medical Center
Updated on 27 January 2021
nitric oxide
nitrite
leg ulcer
thalassemia

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.

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 and randomize them to be 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 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

Details
Condition SICKLE CELL ANEMIA, Sickle Cell Disease
Treatment Placebo, Topical Sodium Nitrite
Clinical Study IdentifierNCT02863068
SponsorMontefiore Medical Center
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Sickle Cell Disease or SICKLE CELL ANEMIA?
Do you have any of these conditions: SICKLE CELL ANEMIA or Sickle Cell Disease?
Do you have any of these conditions: SICKLE CELL ANEMIA or Sickle Cell Disease?
Do you have any of these conditions: Sickle Cell Disease or SICKLE CELL ANEMIA?
Subjects must have a diagnosis of sickle cell disease (SS, SC, S-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 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 PDE5 inhibitors, such as sildenafil, 4 days prior to screening
Pregnant women (urine or serum 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)
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