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Table 2 Outcomes and between group comparisons across time for peak pressure, forefoot pressure time integral, total contact area and forefoot rate of loading

From: A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial

Outcome

Custom-made functional

Prefabricated

Overall significance*

 

Baseline

6-months

Baseline

6-months

(all randomised)

 

Actual

%

95% CI

Actual

%

95% CI

Actual

%

95% CI

Actual

%

95% CI

 

Peak pressure reduction kPa

189

37

40, 33

239

37

42, 33

199

35

39, 31

187

31

34, 26

F=2.687

 

(111)

(15)

 

(171)

(14)

 

(115)

(15)

 

(141)

(17)

 

Eta2=0.023

             

p=0.104

Forefoot pressure time integral reduction kPa.sec

14

27

29, 24

18

30

32, 27

12

22

25, 20

15

24

26, 21

F=11.276

 

(10)

(11)

 

(12)

(10)

 

(7)

(8)

 

(12)

(10)

 

Eta2=0.089

             

p=0.001

Total contact area increase mm 2

4285

32

30, 35

2443

15

13, 16

3827

29

27, 32

2395

15

14, 16

F=1.66

 

(1464)

(10)

 

(1147)

(5)

 

(1183)

(9)

 

(803)

(5)

 

Eta2=0.014

             

p=0.20

Forefoot rate of loading reduction KPa/sec

4

3

6, 0.4

7

4

8, 0.6

7

6

9, 3

6

3

6, 0.7

F=0.225

 

(11)

(13)

 

(16)

(14)

 

(13)

(11)

 

(17)

(13)

 

Eta2=0.002

             

p=0.636

  1. Values are mean and (SD).
  2. % is the actual difference expressed as a percentage of ‘no-insole’.
  3. *ANOVA; significance of difference in % change between custom-made functional and prefabricated insoles over 6 months.