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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.