Novel insole design for diabetic foot ulcer management

Around the world, over 400 million people suffer from diabetes. In a chronic diabetic condition, the skin underneath the foot often becomes extremely soft and brittle, resulting in the development of foot ulcers. In literature, a plethora of footwear designs have been developed to reduce the induced stresses on a diabetic foot and to consequently prevent the incidences of foot ulcers. However, to date, no insole design exists which can handle post-ulcer diabetic foot conditions without hindering the mobility of the patients. In the current work, a novel custom insole design with arch support and ulcer isolations was tested for effective stress reduction in a diabetic foot with ulcers using finite element modeling. A full-scale model of the foot was developed with ulcers of different geometries and sizes at the heel and metatarsal regions of the foot. The stresses at the ulcer locations were quantified for standing and walking with and without the novel custom insole model. The effect of material properties of the insole on the ulcer stress reduction was quantified extensively. Also, the effectivity of a novel synthetic skin material as the insole material was tested for stress offloading at the ulcers and the rest of the foot. From the analyses, peak stress reductions were observed at the ulcers up to 91.5% due to the ulcer isolation in the novel custom insole design and the skin-like material. Specifically, the ulcer isolation feature in the insole was found to be approximately 25% more effective in peak stress reduction for commonly occurring ulcers with irregular geometry, over the tested regular circular ulcer geometry. Also, a threshold material stiffness was found for the custom insole, below which the peak stresses at the ulcers did not decrease any further. Based on this information, a working prototype of the custom insole was developed with custom ulcer isolations, which will be subjected to further testing. The results of this study would inform better custom insole designing and material selection for post-ulcer diabetic conditions, with effective stress reduction at the ulcers, and the possibilities of preventing further ulceration.