Nitric Oxide-Releasing Solution (NORS), a Novel Potential Treatment for Diabetic Foot Ulcers
Abstract
Diabetic foot ulcers (DFU) is one of the chronic complications of diabetes mellitus and often requires extensive treatment and contributes to the risk of severe and costly outcomes, including infection, amputation, and mortality. These patients have a low survival prognosis, with a 3-year cumulative mortality rate of 28%, and rates among amputees approaching 50%. Current treatments of infected diabetic wounds usually consist of injectable antibiotic that has a wide range of side effects and may contribute to the development of antibiotic resistance. In the past 20-30 years, an increased use of antibiotics to treat infections, or potential infections, has led to the selection and subsequent increased appearance of antibiotic-resistant species that are more challenging to treat. Given the severity and persistence of the complications, we hypothesize that an effective non-antibiotic treatment stands to have a significant impact on morbidity and mortality for diabetic patients with DFU. SaNOtize has formulated and patented a simple nitric oxide releasing solution (NORS) that has the potential to reduce the bacterial load, associated with diabetic wounds. Nitric oxide (NO) is an efficient broad-spectrum anti-infective agent; therefore, this novel drug has the potential to transform the care of DFU. NORS has been shown to be highly effective in eradicating some of the most common pathogens in DFU and proved safe in clinical trials on Athletes foot and sinusitis patients. In addition to its bactericidal properties, NORS treatment is expected to enhance blood circulation and promote wound healing. In this study, we will recruit 40 male and female participants between 19 and 75 years of age (inclusive) diagnosed with controlled diabetes mellitus who suffer from DFU. We will compare a group of patients receiving NORS treatment to a group of patient receiving a placebo treatment – a salt (sodium chloride) solution. The participant will soak their foot for 30 minutes for 3 days per week for 4 weeks. We aim to confirm that it is safe to treat diabetic patients with NORS. Moreover, we hypothesize that NORS will reduce pathogenic bacteria within the wound bed and thus reduce clinical signs of infection. We anticipate that NORS will be safe and influence wound healing compared to a placebo treated wound. This study proposes the use of NORS, delivered as a foot bath for the treatment of infected DFU, a pervasive, serious complication of diabetes mellitus. As such, this application responds to the Fiscal Year 2019 Peer Reviewed Medical Research Program Diabetes Topic Area, and to the “Research on interventions to prevent or treat diabetes complications, including diabetic retinopathy, nephropathy, neuropathy, and impaired wound healing” Area of Encouragement. Impact of the research: According to the Centers for Disease Control and Prevention (CDC) the prevalence of diabetes is about 8.4% and rising. About 4%-10% of the diabetic population have DFU. Furthermore, several studies have reported that foot ulcers precede approximately 85% of all amputations performed in diabetic patients. From a clinical financial perspective, about a third of diabetes-related costs have been linked to the treatment of DFU. Thus, costs related to DFU health care are approximately $1.5 billion annually, in addition to the cost for management of diabetes alone. The majority of these costs are related to infected foot ulcers hospital admissions. The end goal will be to use NO to treat non-healing and infected wounds. If NORS proves to be safe and effective in treating these wounds, this treatment can have an enormous impact on people’s lives and on the community. Antibiotics can be saved for severe cases, while NORS will become the first line of treatment. As a natural molecule, non-antibiotic, antimicrobial that can enhance wound healing and blood flow, NO has a very high potential to be a beneficial treatment for non-healing a
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010290
Entities
People
- Christopher J. Miller
Organizations
- United States Army