Treating Diabetic Peripheral Neuropathy Using a Novel, Nanotechnology-Based Topical Formulation to Improve Pain, Sensitivity, and Function

Abstract

Diabetes has become one of the largest global healthcare problems of the 21st century. More than 100 million U.S. adults are now living with diabetes or pre-diabetes. The Centers for Disease Control and Prevention (CDC) reports that as of 2015, 30.3 million Americans (9.4% of the U.S. population) have diabetes and 1.5 million Americans are diagnosed with diabetes every year. The population prevalence of diabetes in the US is approaching 10% and is increasing by 5% each year. Annual costs for diabetic management are over $300 billion (USD). It has been estimated that about 27% of health-care costs of diabetes can be attributed to Diabetic Peripheral Neuropathy (DPN). DPN is the most common complication associated with diabetes mellitus and causes a broad spectrum of neuropathic complications, including acute and chronic forms, affecting each level of the peripheral nerves. DPN has a lifetime prevalence of approximately 50% and is the most common diabetic complication. DPN is a leading cause for disability due to foot ulceration and amputation, gait disturbance, and fall-related injury. Approximately 20% to 30% of patients with DPN suffer from neuropathic pain. DPN significantly lowers quality of life and substantially increases health costs associated with diabetes. There are several treatment options currently available, including vitamins, physical therapy, or topical interventions which have shown limited efficacy. The most common drugs (Gabapentin, Pregabalin) used to treat neuropathic symptoms have limited effectiveness and are frequently associated with substantial side effects. Overall, most patients are dissatisfied with their treatment and many of them are actively looking for better solutions. Ongoing research is needed to identify efficacious, safe, and minimally invasive therapies that provide optimal benefit and minimal harm, with the goal of reducing pain severity, improving function, and improving quality of life. Technological advancements have allowed for the incorporation of nanotechnology into the development of new innovative therapies; yet, there remains a paucity of data surrounding them. The paper summarizes the results of an approved Institutional Review Board (IRB) minimal risk, observational study-in order to evaluate the utilization of gas nanobubbles for treating foot Diabetic Peripheral Neuropathy (DPN) Symptoms. The study used patient perceptions and physician reported clinical assessments, to evaluate the efficacy and safety of novel nanotechnologyformulated, topically-applied hydrogel emulsion, screen for unanticipated adverse effects and proof of concept. The hydrogel emulsion consists of distilled water containing UltraFine Nanobubbles (UFNBs) of O2 and CO2 for the symptomatic treatment of DPN. Outcomes show that a considerable percent of patients experienced 50% or more improvement in their pain level across the different types of pain (tingling, numbness and burning pain) and the improvements are statistically significant. OriGinaL rESEarcH