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Table 5 Site of Highest Pressure

From: A randomised controlled trial and cost-consequence analysis of traditional and digital foot orthoses supply chains in a National Health Service setting: application to feet at risk of diabetic plantar ulceration

  n Control Orthotic   Orthotic Effect
Mean (SD) Mean (SD) Mean (SD) 95% CI Wilcoxon Rank
(kPa) (kPa) (%) (LB - UB) Z p
Traditional Supply Chain
0 M 26 309.67 (101.33) 261.52 (110.67) 14.91 (20.56) (5.89–22.87) −2.679 0.007
6 M 22 251.12 (64.98) 209.84 (63.83) 16.71 (17.25) (9.06–24.35) −3.652 0.000
Digital Supply Chain
0 M 26 318.95 (109.78) 240.03 (113.36) 24.43 (20.18) (16.27–32.58)¥ −4.026 0.000
6 M 19 321.32 (90.33) 279.74 (90.05) 12.41 (20.23) (2.65–22.16) −2.334 0.020
Difference T-D M-W U p T-D M-W U p   T-D t p 95% CI   
0 M   −9.28 355 0.756 21.49 279 0.280   −9.520 −1.695** 0.096 (−20.80 to 1.76)  
6 M   −70.20 316 0.005 −69.90 312 0.007   4.300 0.726** 0.473 (−7.72 to 16.31)  
  1. LB Lower Bound, ↑: Increase in pressure for custom orthotics compared to flat control, ↓: Decrease in pressure for custom orthotics compared to flat control. Statistical significant difference between control and orthotic was assessed via related samples Wilcoxon Rank test ǂ: p < 0.05, ф: p < 0.01. T-D: Mean for Traditional group minus Mean for Digital Group. Non-Inferiority was assessed against a predefined margin of 11.29%. ¥:Lower bound of the 95% Confidence interval for the intervention effect was greater than the NI margin