SBIR-STTR Award

Results Group, LLC, in collaboration with the Southern Arizona Limb Salvage Alliance (SALSA) and other stakeholders will, in this 6-month program, establish proof of principle that non-motorized footwear can translate biomechanical leverage to confer similar load-reducing benefits as found in Total Contact Casts improving return to employment and healthy function. Aligned with patient-centered care and a Triple Aim (better care for individuals, populations, and lower utilization costs), our goals are to bring novel footwear towards commercialization which reduce plantar loading and accelerate and improve rehabilitation after Diabetic Foot Ulcer and minimize its reoccurrence towards helping people resume and maintain full employment and function. We propose the following objectives: 1) Iterative prototyping of non-motorized load-reducing footwear, integrating digital instrumentation to enable objective clinical measurement 2) Limited performance testing in both healthy volunteers and target diabetic patient population 3) Capturing data for future digital modeling. Anticipated outcomes of this work enable Researchers, Orthotics & Prosthetics Companies, and Footwear Companies to see new data that illuminates the opportunities for biomechanical leverage in footwear construction to off-load plantar pressure without motor assist. The expected products are: 1) two prototype pair of pressure-reducing footwear, 2) instrumentation to characterize plantar pressure as well as lateral & frontal pressure peripheral to the ankle, 3) a plan for Phase II effort.

The assistive exo-skeletal footwear promises to help people regain activities of daily living and to resume and maintain full employment by reducing load on the forefoot, reducing fall risk and augmenting foot propulsion that was lost due to foot amputation, ulceration and claudication. Because the exoskeleton will be inserted into diabetic footwear, it carries the risks associated with use of that footwear, which includes patients’ issues of abandonment and non-adherence, we propose the following objectives: 1) “Agile’ design improvements of off-loading/propulsive exoskeleton footwear based upon in-depth human factors analysis 2) biomechanical performance testing of the refined footwear in both healthy volunteers and target diabetic patient population 3) Deploying the prototypes for use into patients’ home environment and evaluating extended use as a means to validate the human-centered design work. Anticipated outcomes of this work will benefit Patients, Researchers, Diabetic Footwear Companies and Orthotics & Prosthetics Companies through the expected products: 1) a new set of qualitative human factors metrics based upon in-depth in-home patient interviews, 2) biomechanical performance testing results, 3) in-home evaluation results to understand the human factors that maximize adoption and long term adherence. 4) optimized design specifications for exo-skeletons based on the human factors .