Virtually optimized insoles for offloading the diabetic foot: A randomized crossover study. (26th July 2017)

• Record Type: Journal Article
• Authors: Telfer, S.; Woodburn, J.; Collier, A.; Cavanagh, P.R.
• Is Part Of: Journal of biomechanics. Volume 60(2017)
• Page Start: 157
• Page End: 161
• Publication Date: 2017-07-26
• Subjects: Diabetic foot disease -- Plantar ulcer -- Insole -- Finite element analysis -- Offloading -- 3D printing; Animal mechanics -- Periodicals; Biomechanics -- Periodicals; Biomechanics -- Periodicals; Mécanique animale -- Périodiques; Biomécanique -- Périodiques; Electronic journals; 571.4305
• DOI: 10.1016/j.jbiomech.2017.06.028
• Languages: English
• ISSNs: 0021-9290

Abstract

Abstract: Integration of objective biomechanical measures of foot function into the design process for insoles has been shown to provide enhanced plantar tissue protection for individuals at-risk of plantar ulceration. The use of virtual simulations utilizing numerical modeling techniques offers a potential approach to further optimize these devices. In a patient population at-risk of foot ulceration, we aimed to compare the pressure offloading performance of insoles that were optimized via numerical simulation techniques against shape-based devices. Twenty participants with diabetes and at-risk feet were enrolled in this study. Three pairs of personalized insoles: one based on shape data and subsequently manufactured via direct milling; and two were based on a design derived from shape, pressure, and ultrasound data which underwent a finite element analysis-based virtual optimization procedure. For the latter set of insole designs, one pair was manufactured via direct milling, and a second pair was manufactured through 3D printing. The offloading performance of the insoles was analyzed for forefoot regions identified as having elevated plantar pressures. In 88% of the regions of interest, the use of virtually optimized insoles resulted in lower peak plantar pressures compared to the shape-based devices. Overall, the virtually optimized insoles significantly reduced peak pressures by a mean of 41.3 kPa ( p < 0.001, 95% CI [31.1, 51.5]) for milled and 40.5 kPa ( p < 0.001, 95% CI [26.4, 54.5]) for printed devices compared to shape-based insoles. The integration of virtual optimization into the insole design process resulted in improved offloading performance compared to standard, shape-based devices. Clinical trial registration: ISRCTN19805071, www.ISRCTN.org.