TY - JOUR
T1 - Virtually optimized insoles for offloading the diabetic foot: a randomized crossover study
AU - Telfer, S.
AU - Woodburn, J.
AU - Collier, A.
AU - Cavanagh, P.R.
N1 - Acceptance date from journal webpage
AAM: 12m embargo
Funding note from AAM:
Funding: ST was funded through the People Programme (Marie Sklodowska-Curie Actions) of the European Union’s Seventh Framework Programme (FP7 2007-2013) under REA Grant
Agreement No. PIOF-GA-2012-329133. The funders had no input into the design, analysis, or decision to publish.
Embargo period of journal longer than required by funder.
PY - 2017/7/26
Y1 - 2017/7/26
N2 - 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.
AB - 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.
KW - 3D printing
KW - diabetic foot disease
KW - finite element analysis
KW - insoles
U2 - 10.1016/j.jbiomech.2017.06.028
DO - 10.1016/j.jbiomech.2017.06.028
M3 - Article
VL - 60
SP - 157
EP - 161
JO - Journal of Biomechanics
JF - Journal of Biomechanics
SN - 0021-9290
ER -