Smart ankle foot orthosis with adjustable pressure offloading

Active Project Grant Awarded Last action

Award ID
R43DK145409
Recipient
Awarding agency
Obligated
$389,019

Award facts

Completion date 58% complete
Originally
Place of performance
Minneapolis, MN 55414, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

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.

Transactions

Action Obligated Date
Amendment $0
Original award $389,019

Quick answers

Who received award R43DK145409?

R43DK145409 was awarded to Koronis Biomedical Technologies Corp. by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on September 1, 2025.

How much is award R43DK145409 worth?

$389,019 has been obligated on R43DK145409.

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