Introduction
Methods
Study design and population
Management of diabetic foot ulcer
Potential predictive factors
Study main outcome
Variable | Included (n = 1,088) | Dropouts (n = 144) |
p value |
---|---|---|---|
Age (years) | 64.7 ± 12.5 | 68.0 ± 11.6 | 0.003 |
Male sex, n (%)a
| 703 (64.6) | 85 (59.0) | 0.189 |
Duration of diabetes, n (%)a
| 0.418 | ||
<5 years | 148 (14.1) | 19 (13.5) | |
5–10 years | 169 (16.1) | 17 (12.1) | |
>10 years | 731 (69.8) | 105 (74.5) | |
Deep ulcer, n (%)a
| 476 (43.8) | 80 (55.6) | 0.007 |
Size of ulcer, n (%)a
| 0.843 | ||
<1 cm2
| 403 (37.2) | 50 (35.0) | |
1–5 cm2
| 563 (52.0) | 76 (53.1) | |
>5 cm2
| 117 (10.8) | 17 (11.9) | |
Duration of ulcer, n (%)a
| <0.001 | ||
<1 week | 184 (17.0) | 10 (7.0) | |
1 week–3 months | 627 (58.1) | 68 (47.6) | |
>3 months | 269 (24.9) | 65 (45.5) | |
Plantar location, n (%)a
| 493 (48.2) | 62 (46.3) | 0.675 |
Pretibial oedema, n (%)a
| 197 (18.2) | 29 (20.3) | 0.538 |
Heart failure NYHA III–IV, n (%)a
| 117 (10.9) | 23 (16.1) | 0.065 |
Neurological disorder, n (%)a
| 70 (6.5) | 9 (6.3) | 0.918 |
Inability to stand or walk without help, n (%)a
| 107 (9.9) | 15 (10.4) | 0.843 |
Visual impairment, n (%)a
| 164 (15.3) | 19 (13.2) | 0.507 |
ESRD, n (%)a
| 63 (5.8) | 7 (4.9) | 0.639 |
Polyneuropathy, n (%)a
| 826 (78.5) | 105 (76.1) | 0.515 |
Infection, n (%)a
| 591 (57.2) | 82 (61.2) | 0.380 |
PAD, n (%)a
| 505 (47.5) | 78 (56.1) | 0.056 |
Statistical analyses
Results
Clinical outcome
Variable | Patients with PAD (n = 505) | Patients without PAD (n = 558) |
p value |
---|---|---|---|
Age (years) | 69.1 ± 11.2 | 60.5 ± 12.3 | <0.001 |
Male sex, n (%)a
| 321 (65.6) | 366 (63.6) | 0.490 |
Duration of diabetes, n (%)a
| 0.265 | ||
<5 years | 63 (12.9) | 80 (14.9) | |
5–10 years | 72 (14.7) | 93 (17.4) | |
>10 years | 354 (72.4) | 363 (67.7) | |
Deep ulcer, n (%)a
| 266 (52.7) | 200 (35.8) | <0.001 |
Size of ulcer, n (%)a
| 0.002 | ||
<1 cm2
| 173 (34.4) | 219 (39.5) | |
1–5 cm2
| 259 (51.5) | 294 (53.0) | |
>5 cm2
| 71 (14.2) | 42 (7.5) | |
Duration of ulcer, n (%)a
| <0.001 | ||
<1 week | 58 (11.5) | 120 (21.7) | |
1 week–3 months | 296 (58.0) | 318 (57.5) | |
>3 months | 148 (29.5) | 115 (20.8) | |
Plantar location, n (%)a
| 197 (40.9) | 284 (55.0) | <0.001 |
Pretibial oedema, n (%)a
| 111 (22.0) | 83 (14.9) | 0.002 |
Heart failure NYHA III–IV, n (%)a
| 64 (12.7) | 47 (8.5) | 0.027 |
Neurological disorder, n (%)a
| 40 (8.0) | 27 (4.9) | 0.039 |
Inability to stand or walk without help, n (%)a
| 65 (12.9) | 36 (6.5) | <0.001 |
Visual impairment, n (%)a
| 89 (17.9) | 66 (12.0) | 0.007 |
ESRD, n (%)a
| 35 (7.0) | 25 (4.5) | 0.082 |
Polyneuropathy, n (%)a
| 383 (77.2) | 424 (79.3) | 0.429 |
Infection, n (%)a
| 293 (60.9) | 282 (53.4) | 0.016 |
Predictors of healing
Predictor variables | Outcome: healing | ||
---|---|---|---|
OR | 95% CI |
p value | |
Age, per 10 year increase | 1.32 | 1.17–1.49 | <0.001 |
Sex, men vs women | 1.50 | 1.07–1.97 | 0.018 |
Duration of diabetes | 0.712 | ||
5–10 vs <5 yearsa
| 0.96 | 0.56–1.65 | |
>10 vs <5 yearsa
| 1.05 | 0.69–1.60 | |
Depth of ulcer, deep vs superficial | 1.66 | 1.25–2.20 | <0.001 |
Size of ulcer | <0.001 | ||
1–5 vs <1 cm2a
| 2.25 | 1.60–3.17 | |
>5 vs <1 cm2a
| 4.22 | 2.64–6.72 | |
Duration of ulcer | <0.001 | ||
1 week to 3 months vs <1 weeka
| 1.81 | 1.15–2.85 | |
>3 months vs <1 weeka
| 2.61 | 1.60–4.27 | |
Location, plantar vs non-plantar | 0.73 | 0.55–0.98 | 0.035 |
Pretibial oedema, yes vs no | 1.79 | 1.27–2.51 | 0.001 |
Heart failure (NYHA III–IV), yes vs no | 2.03 | 1.35–3.05 | 0.001 |
Neurological disorder, yes vs no | 1.44 | 0.85–2.46 | 0.176 |
Inability to stand or walk without help, yes vs no | 2.50 | 1.62–3.79 | <0.001 |
Visual impairment, yes vs no | 1.36 | 0.94–1.98 | 0.105 |
ESRD, yes vs no | 2.20 | 1.30–3.73 | 0.004 |
Polyneuropathy, yes vs no | 1.41 | 0.98–2.04 | 0.065 |
Infection, yes vs no | 1.47 | 1.09–2.00 | 0.012 |
PAD, yes vs no | 2.31 | 1.72–3.10 | <0.001 |
Variable
| All patients | Patients with PAD | Patients without PAD | ||||||
---|---|---|---|---|---|---|---|---|---|
OR | 95% CI |
p value | OR | 95% CI |
p value | OR | 95% CI |
p value | |
Age, per 10 year increase | 1.28 | 1.11–1.47 | 0.001 | 1.42 | 0.17–1.73 | <0.001 | 1.55 | 0.91–2.63 | 0.105 |
Sex, men vs women | 1.72 | 1.23–2.40 | 0.002 | 1.97 | 1.25–3.11 | 0.003 | – | – | – |
Size of ulcer | <0.001 | <0.001 | 0.008 | ||||||
1–5 vs <1 cm2a
| 2.26 | 1.58–3.22 | 3.22 | 1.95–5.32 | 1.25 | 0.74–2.12 | |||
>5 vs <1 cm2a
| 3.88 | 2.37–6.34 | 3.84 | 1.97–7.48 | 3.48 | 1.62–7.46 | |||
Duration of ulcer | – | – | 0.086 | ||||||
1 week to 3 months vs <1 weeka
| – | – | – | – | 2.14 | 1.05–4.36 | |||
>3 months vs <1 weeka
| – | – | – | – | 2.18 | 0.98–4.84 | |||
Heart failure (NYHA III–IV), yes vs no | 1.55 | 0.99–2.43 | 0.054 | 1.54 | 0.87–2.74 | 0.141 | – | – | – |
Inability to stand or walk without help, yes vs no | 2.00 | 1.27–3.14 | 0.003 | 2.36 | 1.34–4.17 | 0.003 | 1.91 | 0.86–4.24 | 0.112 |
ESRD, yes vs no | 2.51 | 1.41–4.48 | 0.002 | 3.04 | 1.38–6.70 | 0.006 | 2.00 | 0.76–5.25 | 0.161 |
Polyneuropathy, yes vs no | 1.42 | 0.96–2.08 | 0.078 | – | – | – | 1.70 | 0.89–3.25 | 0.108 |
Infection, yes vs no | – | – | – | 1.63 | 1.03–2.58 | 0.036 | – | – | – |
PAD, yes vs no | 1.71 | 1.23–2.37 | 0.001 | N/A | N/A |