DIApedia, LLC, funded by the National Institutes of Health SBIR program, has developed an advanced diabetic foot orthosis system. DIApedia?s TrueContour custom diabetic foot orthoses (CDFO) are designed by combining the patient?s unique foot shape with customized offloading modifications of the orthosis surface that are based on the patient?s unique measured plantar pressure. TrueContour CDFOs have been clinically tested in head-to-head studies against diabetic shoe inserts currently approved by Medicare as ?best practice? and have been shown to 1) operate differently by significantly reducing plantar pressure via precise placement of offloading orthosis modifications (Owings et al. 2008) and 2) provide significant therapeutic distinction in reducing ulceration by 3.4 fold in patients at elevated risk for development of a diabetic plantar ulcer (Ulbrecht et al. 2014). The proposed project will address the remaining key cost drivers in the commercial scale manufacturing and distribution of the TrueContour CDFO. Specifically, improvements to the orthosis design process and development of lower cost foot pressure measurement hardware will enable DIApedia and its commercialization partner to introduce the TrueContour CDFO product to the therapeutic footwear marketplace. For the first time, therapeutic footwear providers and their patients will have access to custom diabetic foot orthoses with demonstrated clinical efficacy in the prevention of foot ulcer recurrence. We will collaborate with our commercialization partner and other key vendors to execute our work plan which is focused on completion of the following late stage development activities: A) Create TrueContour custom insole design functionality in a commercial CADCAM software application. B) Develop and test a low-cost, high resolution plantar pressure measurement system. C) Integrate TrueContour CDFO with our commercial partner?s in-clinic patient data acquisition system.
DIApedia, LLC has developed and scientifically validated a system for the design and production of therapeutic insoles for diabetic patients, the TrueContour custom diabetic foot orthosis (CDFO). In a clinical study, the TrueContour CDFO was shown to be more effective in the prevention of foot ulcer recurrence than Medicare approved diabetic insoles. In this proposal, we will complete late stage development activities to improve the design and manufacturing efficiency and establish the commercial viability of the TrueContour CDFO throughout the existing supply chain.
