A novel graded-stiffness footwear device for heel ulcer prevention and treatment: a finite element-based study.

Diabetic heel ulceration is a serious, destructive, and costly complication of diabetes. In this study, a novel "graded-stiffness" offloading method was proposed. This method consists of heel support with multi-increasing levels of stiffness materials, to prevent and treat heel ulcers. A three-dimensional finite element model of the heel was used to evaluate the novel "graded-stiffness" orthotic device compared to two existing solutions: (1) an insole with a hole under the active ulcer and (2) an insole with a hole filled with a soft material (elastic modulus of 15 kPa). Volumetric exposure evaluation of internal tissues to stress was performed at two volume-of-interests: (1) the area of the heel soft tissues typically at high risk for ulceration, and (2) the soft tissues surrounding the high-risk area. The models predict that the "graded-stiffness" offloading solution is more effective than existing solutions in distributing and reducing heel internal loads, considering both volume-of-interests. Comparing different material gradient combinations for the offloading support reveals considerable variation of the heel stress distribution. In clinical practice, the "graded-stiffness" technological solution enables to form an adaptable and flexible system that can be customized to a specific patient, through adequate selection of the offloading materials, to fit the shape and size of the ulcer. This solution can be made as an off-the-shelf product or alternatively, be manufactured by-demand using 3D printing tools. The proposed novel practical offloading solution has the potential for streamlining and optimizing the prevention and treatment of diabetic heel ulcers.