DIAPEDIA, LLC — Department of Health and Human Services SBIR Phase I: 200

Description

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 $ billion annually in the US Gordois It has als been established that the majority of the CDC annual diabetes related lower extremity amputations are preceded by a foot ulcer Pecoraro et al 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 To design and test rocker and roller shoes with a two layer construction where one of the layers is inside the shoe Specific Aim To incorporate rocker roller apex placement internal rocker placement and insole design based on plantar pressure distribution Specific Aim To examine options for offloading the hallux PUBLIC HEALTH RELEVANCE Complications from diabetic neuropathy including plantar foot ulcers are common costly and can lead to amputation They are caused by too much pressure on the foot in a person with neuropathy Rocker shoes have been shown to be effective in reducing plantar forefoot pressures in diabetic neuropathic patients However widespread use of effective rocker shoe designs is limited due to a variety of factors We propose to design a superior offloading rocker shoe with features that will be more user friendly so that people will be more willing to wear them