Table 3.
Trial outcomes for the ITT population.
| Control groupa (n = 90) | Intervention groupa (n = 90) | Adjusted mean differencea | Statistical significance | |
|---|---|---|---|---|
| Primary outcome | ||||
| Days spent in hospital (cumulated over 1 year) | 13.4 (9.0–17.8) |
7.1 (2.8–11.5) |
6.3 (0.1–12.4) |
p = 0.0458b |
| Secondary outcomes (main) | ||||
| Direct costs (€, cumulated over 1 year) | 7185 (5144–9226) |
3471 (1430–5512) |
3714 (827–6600) |
p = 0.0120b |
| Healing rate (%) | 52.4 (41.3–61.7) |
62.1 (53.2–71.0) |
−9.7 (−21.1 to 2.7) |
p = 0.1246c {p = 0.0025}d |
| Amputation rate (%) | 15.6 (8.1–23.1) |
12.4 (5.2–19.5) |
3.2 (−7.0 to 13.4) |
p = 0.5356c {p = 0.8637}d |
| Secondary outcomes (others) | ||||
| Mean duration of hospitalization (days) | 4.1 (0.8) 2.5‒5.8 |
3.3 (0.8) 1.7–5.0 |
0.8 −1.5 to 3.2 |
p = 0.4947e {p = 0.3448}d |
| Number of DFU per patients | 2.6 (0.3) 2.0–3.2 |
2.0 (0.3) 1.4–2.5 |
0.58 −0.2 to 1.4 |
p = 0.1543b {p = 0.2344}d |
| Delay to first improvement (days) | 77 58–98 |
21 15–37 |
n.a. | p = 0.0002f n.a. |
| Delay to first aggravation (days) | 213 126–319 |
>365 196–(n.a.) |
n.a. | p = 0.0362f n.a. |
| Delay to healing (days) | 98 70–149 |
85 49–113 |
n.a. | p = 0.1031f n.a. |
| Number of DFU follow-up visitsg | 4.2 (0.4) [2.0; 6.0] | 6.7 (0.5) [3.0; 10.0] | n.a. | p < 0.001h – |
| Number of visits from expert nursed | n.a. | 10.0 (0.6) [6.0; 14.0] | n.a. | n.a. |
a
Data given as mean (SE, upper line) and 95% CI (lower line; except for IQR, seeg).
b
ANCOVA model (results confirmed with a GEE model, see text).
c
GEE model.
d
Statistical significance of the covariate (ABI).
e
ANCOVA.
f
Kaplan–Meier survival time analysis (0.75 survival probability; see text).
g
IQR, between square brackets.
h
Statistical significance evaluated with a Wilcoxon test.