New biomechanical models for cumulative plantar tissue stress assessment in people with diabetes at high risk of foot ulceration.

To better understand stress-related foot ulceration in diabetes, the cumulative plantar tissue stress (CPTS) should be quantified accurately, but also feasibly for clinical use. We developed multiple CPTS models with varying complexity and investigated their agreement with the most comprehensive reference model available. We assessed 52 participants with diabetes and high foot ulcer risk for barefoot and in-shoe plantar pressures during overground walking at different speeds, standing, sit-to-stand transitions, and stair walking. Level of these weight-bearing activities along with footwear adherence were objectively measured over seven days. The reference CPTS-model included the pressure-time integrals of each walking stride (barefoot and shod), specified for speed; standing period (barefoot and shod); transition and stair walking stride. We compared four CPTS-models with increasing number of input parameters (models 1-4) with the reference model, using repeated measures ANOVA, Pearson's correlation and Bland-Altman plots. For the clinically-relevant metatarsal 1 region, calculated CPTS was lower for the four CPTS-models compared to reference (Δ770, Δ466, Δ24 and Δ12 MPas/day, respectively). CPTS associated moderately with the reference model for model 1 (r = 0.551) and very strongly for models 2-4 (r ≥ 0.937). Limits of agreement were large for models 1 and 2 (-728;2269 and -302;1233 MPas/day), and small for models 3 and 4 (-43;92 and -54;78 MPas/day). CPTS in models 3 and 4 best agreed with the reference model, where model 3 required fewer parameters, i.e., pressure-time integrals of each walking stride and standing period while barefoot and shod. These parameters need to be included for accurate and feasible CPTS assessment.