Research & Development - Additional Programs
Development of sodium nitrite as treatment for diabetic ulcers and an agent for chronic wound management.
Studies in mouse models of diabetic wounds provide evidence that sodium nitrite therapy significantly enhances closure of diabetic wounds and restoration of tissue perfusion.
Diabetic ulcers or foot wounds occur in diabetic patients who develop critical limb ischemia (CLI). 17% of diabetic patients will develop a foot ulcer within 3 years of disease onset, and 90% of lower extremity amputations result from non-healing wounds. Diabetes-induced CLI is mediated by diabetes-induced heart disease or stroke, which leads to narrowing of the blood vessels and severe lack of blood flow to the extremities.
A critical factor in diabetic critical limb ischemia is reduced biologically available NO, which leads to defective blood vessel function and blunted wound healing response. Studies have shown that diabetic wounds treated with vehicle control remain open and poorly healed 14 days after injury, whereas daily nitrite therapy significantly enhances closure of diabetic wounds and restoration of tissue perfusion.
Development of sodium nitrite as a therapeutic to increase motor and cognitive function while reducing oxidative stress.
Dr. Doug Seals at the University of Colorado has conducted an NIH – supported study investigating the effects of TV1001sr on aging. Using 40 mg TV1001sr and placebo groups, with 34 subjects per group, and the SONIC protocol with little variation, his findings indicated that TV1001sr demonstrated bioactivity through an improvement in FMD, demonstrated a clinical benefit in terms of significant improvement in motor function and cognitive function, and showed a reduction in oxidative stress.