Table 6.
Summary of the Secondary Efficacy Outcomes
| Parameter | FAS (n = 31) | PP (n = 27) | Details |
|---|---|---|---|
| Absolute wound size reduction, (cm2)1 | |||
| Change from baseline at week 12 | 2.4 (14.0)2 | 5.2 (6.6) | Table 7 |
| Complete wound closure | |||
| Subjects with complete closure at week 12, n (%) | 6 (20)2 | 6 (22) | Table 9 |
| Subjects with complete closure at any time up to week 12, n (%) | 7 (23) | 7 (26) | Table 9 |
| Time to complete closure, days3 | Not reached | Not reached | Figure 3a |
| ≥30% wound size reduction | |||
| Subjects with ≥30% reduction at week 12 (responders), n (%) | 21 (70)2 | 21 (78) | Table 9 |
| Subjects with ≥30% reduction at any time up to week 12, n (%) | 26 (84) | 24 (89) | Table 9 |
| Time to ≥30% reduction, days3 | 21 (12; 27) | 15 (9; 27) | Figure 3b |
| Reopening after complete wound closure | |||
| Subjects with wounds reopened at week 12, n (%) | 1 (3.2) | 1 (3.7) | n.a. |
| Granulation, % of wound area | |||
| Day 0 | not evaluable | not evaluable | n.a. |
| Week 12 | not evaluable | not evaluable | n.a. |
| Epithelialization, % of wound area | |||
| Day 0 | not evaluable | not evaluable | n.a. |
| Week 12 | not evaluable | not evaluable | n.a. |
| Exudation | |||
| Wounds with low exudation, n (%) | |||
| Day 0 | 14 (45) | 11 (41) | Table 10 |
| Week 12 | 18 (62)4 | 16 (62)5 | Table 10 |
| Wounds with moderate exudation, n (%) | |||
| Day 0 | 15 (48) | 14 (52) | Table 10 |
| Week 12 | 10 (34)4 | 10 (38)5 | Table 10 |
| Pain score1 | |||
| Day 0 | 3.6 (3.2) | n.a. | Table 11 |
| Week 12 | 2.5 (2.2)2 | n.a. | Table 11 |
| QOL6 | |||
| Dermatology Life Quality Index7 | |||
| Day 0 | 9.5 (4–16)2 | n.a. | Table 12 |
| Week 12 | 6.0 (3–12)2 | n.a. | Table 12 |
Abbreviations: CI, confidence interval; FAS, full analysis set; IQR, interquartile range; n.a., not applicable; PP, per-protocol set.
1
Mean (SD).
2
n = 30.
3
Median (95% CI).
4
n = 29.
5
n = 26.
6
Owing to space limitations, the Short Form (36) Health Survey subscale scores (which remained virtually unchanged during the efficacy follow-up) are not shown in this table but are given in Table 12.
7
Median (IQR).