Novel Rocker Shoes for Offloading Diabetic Feet

Period of Performance: 09/17/2015 - 09/16/2016

$250K

Phase 1 SBIR

Recipient Firm

DIApedia, LLC
State College, PA 16801
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): Diabetes related foot ulcers are common and their prevalence is likely to increase as the prevalence of diabetes increases. The cost of treating of diabetic foot ulcers is estimated at over $10 billion annually in the US (Gordois 2003). It has als been established that the majority of the ~60-70,000 (CDC) annual diabetes related lower extremity amputations are preceded by a foot ulcer (Pecoraro et al. 1990). Since plantar neuropathic foot ulcers are related to high plantar pressure, plantar mechanical offloading is essential to successful prevention. Rigid rocker and roller shoes have been shown to be one of the most successful footwear interventions for the reduction of plantar pressure under the metatarsal heads. However, certain aspects of current rocker shoe designs (e.g., shoe height, weight and appearance) have prevented more widespread use in diabetic neuropathic patients. In this study, we propose to develop novel patient-specific rocker and roller shoes in which the offloading is facilitated by surface geometry that is both external and internal to the shoe. The resulting shoe will not have the extreme external angle typical of previous rockers and, together with personalization based on plantar pressure distribution, it should overcome the first three of the drawbacks of traditional rocker shoes mentioned above. No prior research has specifically attempted to address modifications that may enhance hallux offloading. We propose the following specific aims: Specific Aim #1: To design and test rocker and roller shoes with a two-layer construction - where one of the layers is inside the shoe. Specific Aim #2: To incorporate rocker/roller apex placement, internal rocker placement, and insole design based on plantar pressure distribution. Specific Aim #3: To examine options for offloading the hallux.