SHEAR & PRESSURE REDUCING INSOLES FOR THE DIABETIC FOOT

We will evaluate the feasibility of the ShearSoleTM novel insole to reduce pressure and shear forces on the foot. No commercially available insoles are designed to reduce shear. Although insurance providers spend millions on diabetics? therapeutic insoles, there is no scientific data about shear or pressure reduction. We will evaluate the optimal bonded materials from Phase I compared to the ShearSole TM design using the same combination of viscoelastic materials. We will evaluate 2 patient groups of 150 patients per arm (300 total) in an 18 month trial. The control group patient arm will wear a traditional bonded insole whereas another the second arm will receive the ShearSoleTM. At baseline, and at the end of the 18 month trial, in-shoe gait lab and in vitro biomechanical parameters will measure pressure, shear, and material properties as these change with wear. This Phase II eighteen (18) month clinical trial will evaluate the effectiveness of ShearSoleTM reducing the incidence of diabetic ulcers. The overall study hypothesis is that ShearSole TM will provide significant shear reduction as compared to traditional insoles without sacrificing pressure reduction characteristics or durability. In the long-term, this technology will be incorporated into removable cast walkers (to heal ulcers), wheelchair cushions and mattress pads (to prevent development of decubitus ulcers).