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Shear stresses have been implicated in the formation of diabetes-related foot ulcers. The aim of this study was to evaluate the effect of a novel shear-reducing insole on the thermal response to walking, balance, and gait. Twenty-seven diabetes peripheral neuropathy patients were enrolled and asked to take 200 steps in both intervention and standard insoles. Thermal foot images of the feet were taken at baseline (1) following a 5-minute temperature acclimatization and (2) after walking. Testing order was randomized, and a 5-minute washout period was used between testing each insole condition. Sudomotor function was also assessed. Gait and balance were measured under single and dual task conditions using a validated body worn sensor system. The mean age was 65.1 years, height was 67.3 inches, weight was 218 pounds, and body mass index was 33.9, 48% were female, and 82% had type 2 diabetes. After walking in both insole conditions, foot temperatures increased significantly in standard insoles. The intervention insole significantly reduced forefoot and midfoot temperature increases (64.1%, P = .008; 48%, P = .046) compared to standard insoles. There were significant negative correlations with sudomotor function and baseline temperatures (r = .53-.57). The intervention demonstrated 10.4% less gait initiation double support time compared to standard insoles (P = .05). There were no differences in static balance measures. We found significantly lower forefoot and midfoot temperature increases following walking with shear-reducing insoles compared to standard insoles. We also found improvements in gait. These findings merit future study for the prevention of foot ulcer., (© 2014 Diabetes Technology Society.)

Background: Many of the physiological changes that lead to diabetic foot ulceration, such as muscle atrophy and skin hardening, are manifested at the foot-ground interface via pressure and shear points. Novel shear-reducing insoles have been developed, but their magnitude of shear stiffness has not yet been compared with regular insoles. The aim of this study was to develop an apparatus that would apply shear force and displacement to an insole's forefoot region, reliably measure deformation, and calculate insole shear stiffness., Methods: An apparatus consisting of suspended weights was designed to test the forefoot region of insoles. Three separate regions representing the hallux; the first and second metatarsals; and the third, fourth, and fifth metatarsals were sheared at 20 mm/min for displacements from 0.1 to 1.0 mm in both the anteroposterior and mediolateral directions for two types of insoles (regular and shear reducing)., Results: Shear reduction was found to be significant for the intervention insoles under all testing conditions. The ratio of a regular insole's effective stiffness and the experimental insole's effective stiffness across forefoot position versus shear direction, gait instance versus shear direction, and forefoot position versus gait instance was 270% ± 79%, 270% ± 96%, and 270% ± 86%, respectively. The apparatus was reliable with an average measured coefficient of variation of 0.034 and 0.069 for the regular and shear-reducing insole, respectively., Conclusion: An apparatus consisting of suspended weights resting atop three locations of interest sheared across an insole was demonstrated to be capable of measuring the insole shear stiffness accurately, thus quantifying shear-reducing effects of a new type of insole., (© 2013 Diabetes Technology Society.)