Diabetic Foot Ulcer Healing by Load Relieving Dressing

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DESCRIPTION (provided by applicant): In the US at least 200,000 diabetes related foot ulcers per year affect patients and the majority of the more than 80,000 lower extremity amputations performed in diabetic patients per year are preceded by a foot ulcer. Usual care ulcer healing rates are typically only about 30% in 20 weeks, yet a total contact cast (TCC) can heal > 90% of ulcers in 8 weeks on average. However, acceptance of the TCC by providers is poor for a number of reasons and thus efficacious alternatives must be found. The present proposal seeks to demonstrate the feasibility of a prototype Load Relieving Dressing (LRD) using quantitative methods to measure plantar pressures on the foot in patients with deformities that typically cause plantar ulcers, after the mechanical threshold for healing has been defined in ulcer patients. Once feasibility of the dressing concept has been demonstrated we will follow up with a phase II proposal in which finite element modeling will be used to refine the LRD. This product not only has commercial potential, but also offers the possibility of putting a tool into the hands of providers which could heal many ulcers faster than is usual at present and could therefore prevent many lower extremity amputations.