Novel In-Shoe Exoskeleton for Offloading of Forefoot Pressure for Individuals With Diabetic Foot Pathology

Introduction: Infected diabetic foot ulcers are the leading cause of lower limb amputation. This study evaluated the ability of in-shoe exoskeletons to redirect forces outside of body and through an exoskeleton as an effective means of offloading plantar pressure, the major contributing factor of ulceration. Methods: We compared pressure in the forefoot and hind-foot of participants (n = 5) shod with novel exoskeleton footwear. Plantar pressure readings were taken during a 6-m walk at participant’s self-selected speed, and five strides were averaged. Results were taken with Achilles exotendon springs disengaged as a baseline, followed by measurements taken with the springs engaged. Results: When springs were engaged, all participants demonstrated a decrease in forefoot pressure, averaging a 22% reduction (P < .050). Patient feedback was universally positive, preferring the exotendon springs to be engaged and active. Conclusions: Offloading is standard of care for reducing harmful plantar pressure, which may lead to foot ulcers. However, current offloading modalities are limited and have issues. This proof-of-concept study proposed a novel offloading approach based on an exoskeleton solution. Results suggest that when the novel exoskeletons were deployed in footwear and exotendon springs engaged, force was successfully transferred from the lower leg through the exoskeleton-enabled shoe to ground, reducing load on the forefoot. The results need to be confirmed in a larger sample. Another study is warranted to examine the effectiveness of this offloading to prevent diabetic foot ulcer, while minimizing gait alteration in daily physical activities.