Table 1.
Demographics and baseline characteristics of the ITT population
| Demographics of the study population and baseline parameters of the DFU in the ITT population |
Total n=345 (100%) |
NPWT n=171 (49.6%) |
SMWC n=174 (50.4%) |
| Male Female |
267 of 345 (77.4%) 78 of 345 (22.6%) |
133 of 171 (77.8%) 38 of 171 (22.2%) |
134 of 174 (77.0%) 40 of 174 (23.0%) |
| Age (years) (n=345), mean (SD) | 67.8 (11.9) | 67.6 (12.3) | 68.1 (11.5) |
| Height (n=340) (in cm), mean (SD) | 174.1 (12.4) | 173.4 (14.6) | 174.8 (9.9) |
| Weight (n=335) (in kg), mean (SD) | 93.3 (22) | 92.7 (21.5) | 93.8 (22.6) |
| Localisation of the ulcer | |||
| Regio calcanea Dorsum pedis Planta pedis Metatarsalia Phalanges distales Phalanges mediales Phalanges proximales Hallux Digitus pedis II Digitus pedis III Digitus pedis IV Digitus minimus |
39 (11.3%) 20 (5.8%) 56 (16.2%) 147 (42.6%) 64 (18.6%) 28 (8.1%) 40 (11.6%) 42 (12.2%) 22 (6.4%) 14 (4.1%) 20 (5.8%) 25 (7.2%) |
17 (9.9%) 13 (7.6%) 30 (17.5%) 73 (42.7%) 31 (18.1%) 14 (8.2%) 21 (12.3%) 24 (14%) 10 (5.8%) 7 (4.1%) 7 (4.1%) 12 (7.0%) |
22 (12.6%) 7 (4.0%) 26 (14.9%) 74 (42.5%) 33 (19%) 14 (8.0%) 19 (10.9%) 18 (10.3%) 12 (6.9%) 7 (4.0%) 13 (7.5%) 13 (7.5%) |
| Type of ulcer | |||
| Primary ulcer Recurrence |
279 of 342 (80.9%) 63 of 342 (18.3%) |
136 of 170 (79.5%) 34 of 170 (19.9%) |
143 of 172 (82.2%) 29 of 172 (16.7%) |
| Duration of ulcer (days) | |||
| n Mean (SD) Median (IQR) Min – Max |
335 189.7 (360.2) 83 (136) 0–4468 |
168 217.1 (458.1) 81 (140) 0–4468 |
167 162.1 (220) 85 (132) 0–1826 |
| Wound surface area at randomisation (mm2) | |||
| Mean (SD) Median (IQR) Min-Max |
1101 (2543) 491 (1079) 12–40 773 |
1060 (1536) 550 (1217) 20–13 188 |
1141 (3247) 471 (1007) 12–40 773 |
| Wound surface area at randomisation for small wounds (mm2) | |||
| n Mean (SD) Median (IQR) Min-Max |
173 213 (136) 188 (220) 12–484 |
83 212 (138) 176 (220) 20–484 |
90 213 (135) 196 (222) 12–471 |
| Wound surface area at randomisation for large wounds (mm2) | |||
| n Mean (SD) Median (IQR) Min-Max |
172 1995 (3377) 1276 (1482) 491–40773 |
88 1860 (1805) 1364 (1242) 520–13188 |
84 2135 (4474) 1242 (1708) 491–40773 |
Data are number (n) and percentage (%), mean and standard deviation (SD), median and interquartile range (IQR), and minimum – maximum (min – max). ‘n=’ is stating the number of patients with actual available information. Based on the median wound surface area of all included patients, the wounds were divided into an a priori planned subgroup of large (median wound surface area ≤484 mm² and a subgroup of small wounds (median wound surface area >484 mm²).
DFU, diabetic foot ulcer; ITT, intention to treat; NPWT, negative pressure wound therapy; SMWC, standard moist wound care.