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 healing The gold standard for offloading to heal is the total contact cast TCC However the TCC requires significant expertise to use and the TCC and other more effective offloading devices are disliked by patients The overall goal of this project is to exploe whether orthoses designed using individual patient plantar pressure and shape can provide adequate offloading to enable plantar ulcer healing Orthoses designed with these inputs have previously been shown to be more effective than orthoses designed based only on shape and expert opinion in preventing plantar ulcer recurrence in the metatarsal head MTH region Ulbrecht Hurley et al The following specific aims will guide the Phase I activities Specific Aim To design an in shoe orthosis that will optimize offloading of a specific MTH related plantar pressure point This will be accomplished by expanding and modifying the TrueContour r technology into the TrueContour r UHeal device Specific Aim To test the offloading efficacy of TrueContour r UHeal against the TCC and a removable cast walking boot RCW Specific Aim To explore healing rates in a group of carefully supervised patients using TrueContour r UHeal as designed and evaluated in Specific Aims and If these Specific Aims are accomplished the next step would be a randomized controlled trial RCT to determine efficacy of the new product compared with TCCs If such an RCT were to be successful there would be a strong commercial opportunity for a new healing product PUBLIC HEALTH RELEVANCE Ulcers on bottoms of feet of diabetic people are common costly and can lead to amputation They are caused by too much pressure on the foot in a person with neuropathy While many ulcers could be healed by complete non weight bearing this is not practical Casting and walking boots are also successful but they interfere with many activities of daily life and increase risk of falling We propose to design patient specific insole for healing that can be placed in shoes We believe that such shoes will be more user friendly so that people will be more willing to wear them