Diabetes-induced peripheral neuropathy can lead to the development of diabetic foot ulcers
(DFUs), which can have a devastating effect on patients' lives and can lead to life
threatening infection, amputations, and even death. Conventional treatment of DFUs are time
consuming, burdensome, costly, and often do not treat the root cause of the problem. Even
with proper care, ulcers can take a significantly longer time to heal in diabetic patients
due to the altered physiology which does not allow for the proper nutrients and healing
factors to mobilize to the site of injury, leaving these ulcers with a poor chance of healing
and at high risk for infection and possible amputation. Supplemental immunonutrition therapy
may offer a viable, low cost, rapidly scalable, and widely available approach to enhance the
body's ability to heal itself. This prospective, randomized pilot study will evaluate the
effect of a 6-week daily oral course of a specific combination of immunonutrients,
L-Arginine, Omega-3 fatty acids, and Vitamin C, on wound healing in diabetic patients with
chronic lower extremity ulcers compared to traditional standard of care. The deliverables of
this clinical project will serve to advance a cost-effective added strategy to address a
significant unmet clinical need in treatment for the diabetic patient population. Study
outcomes will lay the foundation for a multi-site clinical trial to establish the efficacy
and cost-effectiveness of this strategy across the health care system.