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Table 1 Comparing patients with infected diabetic foot ulcers; with and without gentamicin-sponges

From: A randomized, controlled study to investigate the efficacy and safety of a topical gentamicin-collagen sponge in combination with systemic antibiotic therapy in diabetic patients with a moderate or severe foot ulcer infection

n = 88 No sponges (control arm)   Sponges (investigator arm)
n = 45 p value* n = 43
Female sex 16 (36%) 0.21 10 (23%)
Median age 71 years 0.40 72 years
Median body mass index 28.3 kg/m2 0.39 30.3 kg/m2
Moderate diabetic foot infection 38 (84%) 0.38 39 (91%)
- Infected ulcer at toe level 23 (51%) 0.12 29 (67%)
Median Wound Score at inclusion 18 points 0.78 18 points
- Median number of infected ulcers 1 0.44 1
Median leukocyte count at inclusion 10.3 G/L 0.24 9.3 G/L
Median serum creatinin level at inclusion 87 umol/L 0.29 106 umol/L
Staphylococcus aureus (methicillin-susceptible) 25 (56%) 0.09 16 (37%)
Streptococci 7 (16%) 0.16 12 (28%)
Gram-negative pathogens 14 (31%) 0.30 18 (42%)
- Pseudomonas aeruginosa 1 (2%) 0.15 4 (9%)
Median duration of systemic antibiotics 21 days 0.19 21 days
- Oral antibiotic therapy from the start 26 (58%) 0.69 23 (53%)
Median number of prior surgeries 0 0.97 0
- Prior partial amputation 9 (20%) 0.53 11 (26%)
Prior revascularisationa 7 (16%) 0.89 7 (16%)
Compliance with off-loading 41 (91%) 0.45 37 (86%)
Total cure & significant improvement 39 (87%) 0.81 38 (88%)
- Total cure; without just improvement 26 (79%) 0.16 31 (94%)
Total pathogen eradication 20 (44%) 0.13 26 (60%)
  1. *Significant p values ≤0.05 (two-tailed) are displayed
  2. aRevascularisation of any arteria in patient’s history, independently of the present diabetic foot ulcer infection