Table 2 Un-adjusted and adjusted hazards ratios for the main study outcomes

Age (SD)

*1.06

[1.02;1.10]

1.00

[0.94; 1.05]

1.01

[0.98;1.04]

1.02

[0.97; 1.06]

*0.98

[0.97;1.00]

*0.97

[0.95; 0.99]

0.99

[0.98;1.00]

0.98

[0.97; 1.00]

Sex (female), ref.: male

*2.58

[1.17;5.65]

2.01

[0.71; 5.72]

0.82

[0.37;1.83]

0.71

[0.24; 2.05]

0.58

[0.33;1.01]

NA

1.01

[0.74;1.38]

1.17

[0.83; 1.64]

Current smoker, ref.: no

0.42

[0.12;1.44]

0.38

[0.07; 2.13]

1.47

[0.63;3.44]

1.77

[0.65; 4.82]

1.48

[0.84;2.60]

1.22

[0.67; 2.22]

1.06

[0.73;1.55]

0.75

[0.50; 1.13]

Any alcohol risk, ref.: no

0.91

[0.40;2.07]

1.41

[0.47; 4.20]

1.97

[0.97;4.01]

2.04

[0.82; 5.05]

1.48

[0.84;2.60]

1.35

[0.98; 1.04]

0.83

[0.61;1.11]

NA

Diabetes duration

1.02

[0.98;1.06]

1.00

[0.95; 1.06]

1.02

[0.98;1.06]

0.98

[0.94; 1.03]

*1.02

[1.00;1.05]

1.01

[0.98; 1.04]

*0.98

[0.96;0.99]

0.98

[0.97; 1.01]

Hypertension, ref.: no

1.61

[0.48;5.39]

0.78

[0.18; 3.40]

1.12

[0.43;2.93]

0.78

[0.22; 2.86]

0.75

[0.43;1.31]

0.85

[0.42; 1.72]

0.81

[0.57;1.16]

0.98

[0.66; 1.45]

Dislipidemia, ref.: no

0.82

[0.36;1.86]

0.57

[0.22; 1.52]

0.82

[0.39;1.71]

0.48

[0.20; 1.15]

0.74

[0.46;1.18]

0.64

[0.38; 1.07]

0.95

[0.70;1.29]

1.06

[0.77; 1.47]

Macrovascular complications, ref.: no

*3.67

[1.58;8.52]

1.08

[0.12; 10.12]

1.19

[0.58;2.43]

1.37

[0.25; 7.63]

1.38

[0.87;2.18]

1.31

[0.56; 3.07]

0.81

[0.60;1.09]

1.00

[0.62 1.60]

Retinopathy, ref.: no

1.17

[0.50;2.72]

1.03

[0.37; 2.86]

*2.97

[1.46;6.04]

*3.39

[1.37; 8.39]

*1.64

[1.03;2.61]

1.17

[0.69; 1.98]

*0.64

[0.47;0.88]

0.67

[0.47; 0.96]

Chronic kidney disease (CKD), ref.: no

2.11

[0.96;4.66]

0.79

[0.28; 2.22]

*2.15

[1.06;4.36]

1.60

[0.66; 3.86]

1.48

[0.92;2.37]

1.68

[0.96; 2.94]

*0.55

[0.40;0.77]

0.73

[0.51; 1.06

History of previous ulcers, ref.: no

0.73

[0.27;1.94]

0.80

[0.23; 2.80]

1.76

[0.85;3.64]

1.28

[0.42; 3.91]

*1.85

[1.14;2.99]

NA

0.73

[0.52;1.00]

NA

History of previous amputation, ref.: no

0.46

[0.06;3.44]

0.34

[0.03; 3.47]

*3.08

[1.32;7.18]

1.30

[0.36; 4.70]

*2.78

[1.48;5.19]

2.62

[1.26; 5.45]

*0.55

[0.33;0.94]

0.64

[0.37; 1.11]

HbA1c (%)

0.99

[0.79;1.24]

1.04

[0.79; 1.36]

1.09

[0.90;1.30]

0.96

[0.77; 1.20]

1.03

[0.91;1.16]

0.98

[0.86; 1.12]

0.98

[0.90;1.06]

1.00

[0.91; 1.08]

BMI

1.00

[0.93;1.08]

1.00

[0.91; 1.10]

0.97

[0.90;1.04]

1.01

[0.92; 1.10]

0.98

[0.93;1.02]

0.97

[0.92; 1.02]

1.02

[0.99;1.05]

NA

Decreased visual acuity, ref.: no

1.03

[0.47;2.26]

0.57

[0.22; 1.51]

1.20

[0.59;2.43]

0.63

[0.27; 1.46]

1.16

[0.74;1.83]

0.93

[0.55; 1.57]

0.80

[0.60;1.07]

1.20

[0.87; 1.66]

Problems with mobility, ref.: no

*3.90

[1.63;9.35]

2.87

[0.84; 9.84]

1.56

[0.77;3.15]

1.23

[0.47; 3.24]

1.16

[0.74;1.83]

1.16

[0.65; 2.07]

*0.64

[0.48;0.86

NA

Need of a caregiver, ref.: no

*5.63

[2.35;13.5]

*3.63

[1.05; 12.61]

2.00

[0.99;4.06]

2.26

[0.92; 5.55]

1.51

[0.95;2.40]

*1.81

[1.03; 3.19]

*0.52

[0.38;0.72]

*0.55

[0.39; 0.79]

Ischemia, ref.: no

*4.30

[1.90;9.74]

*6.41

[2.25; 18.30]

*2.20

[1.08;4.45]

1.52

[0.59; 3.87]

1.56

[0.98;2.50]

1.47

[0.83; 2.62]

*0.62

[0.45;0.85]

0.84

[0.59; 1.18]

Infection, ref.: no

1.07

[0.48;2.38]

*3.06

[1.05; 8.94]

*3.33

[1.57;7.08]

2.26

[0.69; 7.36]

1.38

[0.88;2.17]

1.50

[0.76; 93]

*0.57

[0.42;0.77]

*0.63

[0.42; 0.96]

Deep or very deep (Ref: superficial)

0.50

[0.15;1.69]

*0.09

[0.02; 0.54]

*2.94

[1.45;5.97]

1.95

[0.61; 6.24]

1.49

[0.90;2.45]

0.68

[0.30; 1.54]

*0.55

[0.38;0.80]

0.64

[0.38; 1.07]

DFU Extension: > 1 cm, ref. ≤1

1.09

[0.88;1.34]

0.72

[0.26; 1.94]

0.85

[0.69;1.05]

1.84

[0.82; 4.15]

1.07

[0.94;1.21]

NA

1.00

[0.92;1.08]

NA

R2 Nagelkerke

0.217

0.218

0.126

0.234

Global p-value**

0.572

0.795

0.146

0.837