Foot problems are a major cause of morbidity in individuals with Diabetes Mellitus. Plantar callus is a common problem in this population. Callus formation, a known precursor to diabetic foot ulceration, results from abnormally high shear and torque forces experienced by the foot during weight bearing.

Foot orthoses and properly fitting shoes are discussed in the literature and are recognized as important preventative measures in decreasing the risk of diabetic foot callus, ulceration and eventual amputation. The traditional foot orthosis is fabricated of multiple layers of soft materials that lose their force absorbing mechanical properties with repeated use. The effectiveness of a foot orthosis is not only dependent on the type of materials used, but also on the design of the orthosis. The design of traditional orthoses is static since there are no moveable parts or layers. The effectiveness of the traditional orthosis is

dependent on a total contact interface between the foot and the device, and the ability of the materials to absorb the shear and torque associated with weight bearing during ambulation. Even with appropriately fitted traditional foot orthoses, many patients develop foot ulcerations.

The objective of this project is to design a dynamic foot orthosis (DFO) and assess its effectiveness in dissipating shear and compressive stresses produced at the distal 1/3rd of the foot during ambulation in individuals with diabetic peripheral neuropathy. The efficacy of the dynamic foot orthosis in prevention and reduction of plantar foot of the foot will be compared to the traditional foot orthosis. Computerized measurement and analysis of the in shoe foot pressure at the metatarsal heads and great toe during use of the DFO will be measured and compared to those observed with use of the traditional foot orthosis.

Twenty individuals with known diabetic peripheral neuropathy will participate in the study. Ten participants will be randomly assigned to the dynamic foot orthosis group and ten to the traditional foot orthosis group. During the 12 month orthotic therapy, each subject will be reassessed every
3 months and evaluated for foot ulcer grade, force measurement and repeat foot examination.

In addition to developing an improved orthotic design, this project will also provide clinicians and researchers with new tools for studying the scientific basis of orthotic management in treating diabetic foot ulcer.