Table 4.
Trial outcomes for the PP population.
| Control groupa (n = 72) | Intervention groupa (n = 67) | Adjusted mean differencea | Statistical significance | |
|---|---|---|---|---|
| Primary outcome | ||||
| Days spent in hospital (cumulated over 1 year) | 14.8 9.7–19.8 |
7.1 1.8–12.3 |
7.7 0.4–15.0 |
p = 0.0387b |
| Secondary outcomes (main) | ||||
| Direct costs (€, cumulated over 1 year) | 8088 5622–10555 |
3911 1363–6468 |
4177 618–7737 |
p = 0.0218b |
| Healing rateb (%) | 53.7 44.0–63.4 |
66.5 56.9–76.1 |
−12.8 −25.9 to 0.3 |
p = 0.0559c {p = 0.0006}d |
| Amputation rate (%) | 16.7 8.1–25.4 |
13.4 4.8–22.0 |
3.3 −8.5 to 15.2 |
p = 0.5817c {p = 0.6558}d |
| Secondary outcomes (others) | ||||
| Mean duration of hospitalization (days) | 4.0 (0.7) 2.5‒5.4 |
2.8 (0.8) 1.3–4.3 |
1.16 −0.90 to 3.22 |
p = 0.2667b {p = 0.5926}d |
| Number of DFU per patient | 2.4 (0.3) 1.8–3.0 |
2.0 (0.3) 1.4–2.6 |
0.38 −0.5 to 1.2 |
p = 0.3720b {p = 0.0864}d |
| Delay to 1st improvement (days) | 70.0 46.0–89.0 |
18.0 11.0–30.0 |
n.a. | p = 0.0012e n.a. |
| Delay to 1st aggravation (days) | 176.0 98.0–261.0 |
>365 196–(n.a.) |
n.a. | p = 0.0029e n.a. |
| Delay to healing (days) | 98.0 70.0–149.0 |
80.0 43.0–112.0 |
n.a. | p = 0.1302e n.a. |
| Number of DFU follow-up visitsf | 4.6 (0.4) [2.0; 7.0] | 7.4 (0.6) [3.0; 11.0] | n.a. | p < 0.001g – |
| Number of visits from expert nursef | n.a. | 11.7 (0.6) [9.0; 15.0] | n.a. | n.a. |
a
Data given as mean (SE, upper line) and 95% CI (lower line; except for IQR, seef).
b
ANCOVA.
c
GEE model.
d
Statistical significance of the covariate (ABI).
e
Kaplan–Meier survival time analysis (0.75 survival probability; see text).
f
IQR, between square brackets.
g
Statistical significance evaluated with a Wilcoxon test.