SBIR-STTR Award

We will evaluate thje feasibility of the ShearSole/TM novel insole and reduce pressure and shear forces on the foot's sole. No commercially available insoles are designed to reduce shear. Although insurance providers spend millions on diabetics' therapeutics insoles, there is no scientific data about shear or pressure reduction. We will evaluate 3 combinations of traditional double layer viscoelastic insoles compared to the ShearSole/Tm design using the same 3 combinations of viscoelastic materials. We will use 3 groups of 10 heathy volunteers in a 16 week trial. Health volunteers will wear a traditional insole in one shoe and ShearSole/TM in the other. At baseline and every 4 weeks, in-shoe gait lab and in vitro biomechanical parameters will measure pressure, shear, and material properties as these change with wear. Once Phase I feasibility and safety are established, a Phase II clinical trial will follow to evaluate the effectiveness of ShearSole TM reducing the incidence of diabetic ulcers. In the long-term, this technology will be incorporated into removable cast walkers (to heal ulcers), wheelchair cushions in mattress pads (to prevent development of decubitus 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. PROPOSED COMMERCIAL APPLICATIONS: The low cost ShearSole/Tm shear and pressure relieving insole promises to revolutionize diabetic patient care via a simple procedure of wearing novel insoles in their shoes. Shear and pressure relieving qualities are provided in a novel insole package. This simple means will sere to decrease neuropathic ulcers, amputations and diabetic morbidity. In effect, the ShearSole/Tm, should become the insole of choice for diabetic patients.

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). PROPOSED COMMERCIAL APPLICATION: The low cost of ShearSole TM shear and pressure relieving insole promises to revolutionize diabetic patient care via a simple procedure of weating novel insoles in their shoes. Shear and pressure relieving qualities are provided in a novel insole package. This simple means will serve to decrease neuropathic ulcers, amputations and diabetic morbidity. In effect, the ShearSole TM, should become the insole of choice for diabetic patients.

Thesaurus Terms:
assistive device /technology, biomechanics, consumer product, decubitus ulcer, diabetes mellitus, foot, mechanical stress, technology /technique development clinical trial, diabetes mellitus therapy, disease /disorder prevention /control, elasticity, gait clinical research, human subject, patient oriented research