Wound care product | Country | Study period | Number of patients/study design | Initial ulcer size (cm2) | Mean age | Dressings | Ulcers healed (%/duration) | Reference |
Apligraf | US | 12 w + 3 m (follow-up) | 112 (Apligraf), 96 (saline-moistened gauze), RCT | 2.97 intervention group (IG), 2.83 control group (CG) | 58 IG, 56 CG | Weekly application of Graftskin for a maximum of 4 weeks | 56/12 w IG, 38/12 w CG | Veves et al. 2001 |
Apligraf | US | 6 m + 6 m (follow-up) | 146 (Apligraf plus compression), 129 (compression alone), RCT | 1.33 IG, 1.05 CG | 60.2 IG, 60.4 CG | Maximum of 5 in weeks 0–3, (IG), 1 in weeks 0–8 (CG) | 63/6 m IG, 48.8/6 m CG | Falanga et al. 1998 |
Dermagraft | US | 32 w | 109 (Dermagraft plus conventional therapy, 126 (conventional therapy alone), RCT | ≥ 1 | Not stated | Weekly application of Dermagraft in weeks 0–7 | 38.5/12 w IG, 31.7/12 w CG | Naughton et al. 1997 |
Becaplermin | US | 20 w | Study 1: 57 P, 61 B (30 μg/g); Study 2: *; Study 3: 68 GUC alone, 70 P, 34 B (100 μg/g); Study 4: 122 GUC, 128 B (100 μg/g); Total: 190 GUC, 254 P, 193 B (30 μg/g), 285 B (100 μg/g), 478 B (all doses), review of 4 RCTs | Study 1: 7.2, Study 2: 2.7, Study 3: 2.2, Study 4: 2.9 | Study 1: 61, Studies 2, 3: 58, Study 4: 60 | Becaplermin or placebo gel was applied topically once daily and covered with saline-moistened gauze. | Study 1: 48/20 w B (30 μg/g), 25/20 w P; Study 2: *; Study 3: 44/20 w B (100 μg/g), 36/20 w P, 22/20 w GUC; Study 4: 36/20 w B (100 μg/g), 32/20 w GUC | Wieman 1998 |
Becaplermin | US | 20 w | *, meta analysis of 4 RCTs | Study 1: 9.0 P, 5.5 (30 μg/g); Study 2: *; Study 3: 2.5 GUC, 2.2 P, 1.6 B (100 μg/g); Study 4: 2.5 GUC, 3.2 B (100 μg/g) | Study 1: 58 P, 63 (30 μg/g); Study 2: *; Study 3: 60 GUC, 57 P, 59 B (100 μg/g); Study 4: 60 GUC, 59 B (100 μg/g) | ** | * for efficacy results of individual studies; combined analysis of treatment efficacy: 36/20 w (GUC/P), 42/20 B (30 μg/g), 50/20 B (100 μg/g) | Smiell et al. 1999 |
Becaplermin | US | 20 w | 127 P, 132 B (30 μg/g), 123 B (100 μg/g), RCT | 2.8 P, 2.6 B (30 μg/g), 2.6 B (100 μg/g) | 58 P, 58 B (30 μg/g), 57 B (100 μg/g) | ** | 50/20 w B (100 μg/g), 36/20 w B (30 μg/g), 35/20 w P | Wieman et al. 1998 |