Country |
Germany |
Germany |
Iran |
Israel |
Study design |
RCT (double-blind, placebo controlled) |
RCT (double-blind, placebo controlled) |
RCT (triple-blind, placebo controlled) |
RCT (single blind, standard treatment controlled) |
Total number of patients (%) |
23 (100%) |
84 (100%) |
12 (100%) |
10 (100%) |
Males |
22 (95.6%) |
66 (78.6%) |
3 (25%) |
6 (60%) |
Females |
1 (4.4%) |
18 (21.4%) |
9 (75%) |
4 (40%) |
Mean age (SD) |
61.91 ± 9.27 |
47.55 ± 15.6 |
44.58 ± 7.5 |
67.8 ± 8.6 |
Wound aetiology |
Diabetic ulcers |
Burn and scalding injuries |
Post-traumatic wounds (post free gingival grafting) |
Diabetic ulcers |
Type of treatment |
subcutaneously |
Subcutaneously |
topical |
topical |
Treatment period |
12 weeks |
3 weeks |
2 times (after surgery and 2 days after surgery) |
12 weeks |
Number of patients by arms (%) |
|
Intervention arm |
16 (69.6%) |
45 (53.6%) |
Not applicable (split mouth design) |
5 (50%) |
Control arm |
7 (30.4%) |
39 (46.4%) |
Not applicable (split mouth design) |
5 (50%) |
Number of withdrawals (%) |
|
Intervention arm |
1 (6.2%) |
36 (80%) |
0 (0%) |
0 (0%) |
Control arm |
0 |
28 (71,8%) |
0 (0%) |
0 (0%) |
Number of wounds |
|
Intervention arm |
15 |
40 |
12 |
5 |
Control arm |
17 |
37 |
12 |
5 |
Mean wound size (cm2)
|
|
Intervention arm |
3.78 ± 5.07 |
Not reported |
1.5 |
5.0 ± 4.9 |
Control arm |
4.82 ± 5.47 |
Not reported |
1.5 |
7.5 ± 5.5 |
Number of wounds with complete healing (%) |
|
Intervention arm |
4 (26.7%) |
9 (23%) on day 16 |
12 (100%) on day 28 |
2 (40%) on week 12 |
Control arm |
1 (14.3%) |
11 (30%) on day 16 |
11 (91.7%) on day 28 |
0 (0%) on week 12 |
Mean duration for complete healing (days) |
|
Intervention arm |
44 days |
Not reported |
Not reported |
Not reported |
Control arm |
Not reported |
Not reported |
Not reported |
Not reported |
Follow-up period |
12 weeks |
12 months |
Not reported |
12 weeks |