Contact Pressures Between the Rearfoot and a Novel Offloading Insole: Results From a Finite Element Analysis Study

Pressure offloading is critical to diabetic foot ulcer healing and prevention. A novel product has been proposed to achieve this offloading with an insole that can be easily modified for each user. This insole consists of pressurized bubbles that can be selectively perforated and depressurized to redistribute weight to the nonulcer region of the foot. However, the effect of the insole design parameters, for example, bubble height and stiffness, on offloading effectiveness is unknown. To this end, a 3-dimensional finite element model was developed to simulate contact between the rearfoot and insole. The geometry of the calcaneus bone and soft tissue was based on the medical images of an average male patient, and material properties and loading conditions based on the values reported in the literature were used. The model predicts that increasing bubble height and stiffness leads to a more effectively offloaded region. However, the model also predicts that increasing stiffness leads to increasing contact pressures on the surrounding soft tissue. Thus, a combination of insole design parameters was determined, which completely offloads the desired region, while simultaneously reducing the contact pressure on the surrounding soft tissue. This design is expected to aid in diabetic foot ulcer healing and prevention.