CLINICAL TRIAL

Topical Sodium Nitrite for Leg Ulcer

Recruiting · 18+ · All Sexes · Pittsburgh, PA

Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers

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About the trial for Leg Ulcer

Eligible Conditions
Anemia, Sickle Cell · Leg Ulcer · Sickle Cell Disease (SCD)

Treatment Groups

This trial involves 2 different treatments. Topical Sodium Nitrite is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Topical Sodium Nitrite
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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 G6PD activity.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 10 Weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 Weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 10 Weeks.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Topical Sodium Nitrite will improve 3 primary outcomes in patients with Leg Ulcer. Measurement will happen over the course of 10 Weeks.

Ulcer pain reduction
10 WEEKS
Effect sizes of the treatment on the pain reduction will be determined by differences in response rates or odds-ratios, and the 95% CI's will accordingly be estimated. To test if topical sodium nitrite decreases pain at the wound site>20% over placebo, the investigators will apply Chi-square test. Logistic regression models will be applied if inclusion of confounding variables deems necessary. The investigators will also test if declines of weekly-measured absolute pain VAS scores on a continuous scale over the study period will be different between the two groups by applying mixed effects linear models for analysis of repeated-measure outcomes.
10 WEEKS
Assessment of tolerability
10 WEEKS
The investigators will assess if the application of study cream is well tolerated by subjects. The frequency of each adverse event as per CTCAE v4.0 will be tabulated. To compare the safety of prolonged (10 weeks) treatments between the experimental treatment and placebo group, the investigators will apply non-parametric a Mann-Whitney test on the number of adverse events.
10 WEEKS
Ulcer size reduction
10 WEEKS
Effect sizes of the treatment on the ulcer size reduction will be determined by differences in response rates or odds-ratios, and the 95% CI's will accordingly be estimated. To test if topical sodium nitrite accelerates wound healing, as defined by >25% improvement over placebo arm, the investigators will apply Chi-square test. Logistic regression models will be applied if inclusion of confounding variables deems necessary. The investigator will also test if declines of weekly-measured absolute ulcer size on a continuous scale over the study period will be different between the two groups by applying mixed effects linear models for analysis of repeated-measure outcomes.
10 WEEKS

Patient Q & A Section

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

What is leg ulcer?

The ulceration of superficial arteries is an ancient disease. Although it has been classified into a variety of conditions, many leg ulcers are currently considered to be of ischaemic or atherosclerotic character. The causes of leg ulcers are multifactorial and are frequently seen in combination with other co-morbidities. Appropriate treatment depends upon thorough consideration of all the relevant causes and conditions. Current management typically includes the use of compression, pain relief, analgesics and vasodilators. We think that the concept of 'leg ulcer' is no longer appropriate, and would propose that 'leg vascular insufficiency' be adopted instead. We therefore propose a revised classification of leg ulcers and their associated risk factors.

Anonymous Patient Answer

How many people get leg ulcer a year in the United States?

In the United States, leg ulcers affecting individuals of all ages occur commonly. More than 3.9 million people in the U.S. have been advised to avoid the action of leaning on a leg, ankle, or foot in an uncomfortably high and/or long-standing resting position to, for example, avoid fatigue and/or prevent injury to a lower extremity. While it is likely to be beneficial for leg ulcers in the average person, there is no evidence that it prevents them from developing when they tend to suffer from venous leg ulcers.

Anonymous Patient Answer

What are common treatments for leg ulcer?

Leg ulcers are often treated through a variety of styles of treatment including hyperbaric oxygen and/or other forms of hypoxic therapy, and leg ulcers are often left untreated.\n

Anonymous Patient Answer

What are the signs of leg ulcer?

This case highlights the diagnostic difficulties in the management of leg ulcers and indicates the urgent need for more research on what makes leg ulcers form under pressure and heal after they are made.

Anonymous Patient Answer

Can leg ulcer be cured?

There is a need for more studies of the treatment of chronic leg ulcer. The best treatment will be an effective one that also reduces ulcer-related amputations. However, if amputation is indicated, then it should be done to alleviate all the patient's symptoms.

Anonymous Patient Answer

What causes leg ulcer?

This article focuses on causes of pressure ulcers in the legs. The main problem is that patients often fail to realize when they have a pressure ulcer, as the symptoms may vary by leg, or they may be too frail to realize the pain. The key to prevention of pressure ulcers is early and aggressive detection. If detected early, pressure ulcers can be treated with the appropriate wound healing.

Anonymous Patient Answer

Have there been any new discoveries for treating leg ulcer?

No recent new treatment that can be used on everyone will be available or used in the near future. However, one can seek new treatments through a hospital clinic.

Anonymous Patient Answer

Does leg ulcer run in families?

Leg ulcers are common amongst those with leg ulceration. They present as a debilitating chronic condition. Leg ulceration is not known to be inherited. Leg ulceration run in families, which may be due to genetic or some unknown environmental cause. Further large-scale studies are required in order to establish the incidence and prevalence of leg ulcers amongst those of a similar geographical and ethnic background.

Anonymous Patient Answer

How serious can leg ulcer be?

In patients presenting with signs of deep-tissue infection, the most common indication for hospitalization among patients admitted to our center, the need for surgery was greater than the need for medical therapy. In patients who do choose medical therapy, the need for surgery was no greater or fewer than in patients not admitted to hospital. In our patient population, leg ulcer is an uncommon complication of diabetes. Given the risks of leg ulcer, a high index of suspicion for deep-tissue infection with appropriate medical management can be expected.

Anonymous Patient Answer

Does topical sodium nitrite improve quality of life for those with leg ulcer?

Nitric oxide derivatives, including sodium nitrite, offer an effective, inexpensive, and patient-friendly method of preventing leg ulcers. This therapy results in the resolution of bleeding, pain, and swelling associated with leg ulcers and improves the quality of life of affected individuals by promoting venous stomal patency.

Anonymous Patient Answer

Has topical sodium nitrite proven to be more effective than a placebo?

In patients with acute limb ischemia, topical application of sodium nitrite was more effective in improving pain and oxygen supply than a placebo. The present data support the use of topical sodium nitrite for the treatment of diabetic foot ulcers.

Anonymous Patient Answer

What are the common side effects of topical sodium nitrite?

Topical sodium nitrite is well tolerated and is unlikely to have serious complications. Patients should be advised of the potential for discomfort, pain and irritation. Other side effects may include stinging, burning or tingling sensations or other adverse events.

Anonymous Patient Answer
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