Smart Ankle Foot Orthosis with Adjustable Pressure Offloading

Abstract Koronis Biomedical Technologies (KBT), in collaboration with its clinical partners, proposes to evaluate the feasibility of using an innovative smart offloading Ankle Foot Orthosis (AFO) to treat patients with diabetic foot ulcers (DFU), Charcot neuroarthropathy (CN), and other below-the-knee orthopedic traumas. The incidence of diabetes mellitus type 2 has reached epidemic proportions in the United States. There are 37 million persons with diabetes in the United States, and incidence of the disease is rising rapidly. Within this population, racial and ethnic minorities have a higher burden of diabetes-related complications than non-Hispanic whites. The devastating vascular complications of the disease are precursors to DFU and CN. Numbness due to nerve signal disruption allows repetitive trauma arising from activities of daily living to be unfelt. This trauma may open a DFU, a wound that does not predictably heal. It may also lead to CN, foot bone structure and joint destruction due to inflammation and/or complicated fractures and deformation that arises during fracture healing. Any delay in recovery time for these conditions can lead to complications including infection, amputation, and death. A critical aspect of DFU/CN management is the mitigation of the repetitive plantar pressures and shear forces: Offloading plantar pressure is a cornerstone in the treatment of DFU/CN. Unlike any other product on the market, the proposed AFO’s degree of offloading can be selected using a simple mechanical adjustment. Integrated load cells will provide instantaneous feedback to verify fractional offloading. This will allow clinicians to adjust offloading during weaning when a wound enters remission, encouraging the skin to grow thicker and stronger, with the goal of reducing the risk of recurrence. The AFO will also include therapy adherence measurement that will later be used to provide actionable, helpful encouragement via a smartphone app to remind patients to wear the orthosis, a critical factor in DFU/CN healing.