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Table 2 Characteristics of the randomised clinical trials for establishing effectiveness

From: Systematic review of economic evaluations of human cell-derived wound care products for the treatment of venous leg and diabetic foot ulcers

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
  1. *: See Wieman et al. 1998; **: See Wieman 1998; B: becaplermin; CG: control group; GUC: good ulcer care; IG: intervention group; m: months; P: placebo; RCT: randomised controlled trial; w: weeks.