Parameter | Full analysis set (N = 23) | Per-protocol set (N = 20) | Sourcea |
---|---|---|---|
Absolute wound surface area reduction | |||
Change from baseline at week 12 (cm2)b | 1.7 (0.3–2.8) | 2.0 (0.9–2.9) | Additional file 1: Table S7 |
Complete wound closure | |||
Patients with complete closure at week 12, n (%) | 6 (26) | 6 (30) | Additional file 1: Table S8 |
Patients with complete closure at any time up to week 12, (%) | 6 (26) | 6 (30) | Additional file 1: Table S8 |
Time to complete closure, daysc | Not reached | Not reached | Figure 7D |
≥ 30% wound surface area reduction | |||
Patients with ≥ 30% reduction at week 12 (“Responders”), n (%) | 17 (74) | 17 (85) | Additional file 1: Table S8 |
Patients with ≥ 30% reduction at any time up to week 12, n (%) | 19 (83) | 18 (90) | Additional file 1: Table S8 |
Time to ≥ 30% reduction, daysc | 27 (14; 30) | 22 (14; 30) | Figure 7E |
Reopening after complete wound closure | |||
Patients with wounds reopened at week 12, n (%) | 0 (0) | 0 (0) | n.a |
Exudation | |||
Wounds with low exudation, n (%) | |||
Day 0 | 10 (44) | 7 (35) | Additional file 1: Table S9 |
Week 12 | 12 (52) | 10 (50) | Additional file 1: Table S9 |
Wounds with moderate exudation, n (%) | |||
Day 0 | 11 (48) | 11 (55) | Additional file 1: Table S9 |
Week 12 | 10 (44) | 9 (45) | Additional file 1: Table S9 |
Amputation at target leg | |||
Patients with amputation, n (%) | 1 (4) | 1 (5) | n.a |
Time to amputation, days | 42 | 42 | n.a |
Pain scoreb | |||
Day 0 | 1 (0–3) | n.a | Additional file 1: Table S10 |
Week 12 | 1 (0–2) | n.a | Additional file 1: Table S10 |
Quality of lifed | |||
Dermatology Life Quality Indexb | |||
Day 0 | 6 (1–12) | n.a | Additional file 1: Table S11 |
Week 12 | 4 (0–10) | n.a | Additional file 1: Table S11 |