Healing Diabetic Foot Ulcers with an Offloading Orthosis

Period of Performance: 08/01/2015 - 07/31/2016


Phase 1 SBIR

Recipient Firm

DIApedia, LLC
State College, PA 16801
Principal Investigator


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 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. 2014). The following specific aims will guide the Phase I activities: Specific Aim 1: 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 2: To test the offloading efficacy of TrueContour(r) UHeal against the TCC and a removable cast walking boot (RCW). Specific Aim 3: To explore healing rates in a group of carefully supervised patients using TrueContour(r)- UHeal as designed and evaluated in Specific Aims 1 and 2. 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.