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

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

n = 88	No sponges (control arm)		Sponges (investigator arm)
n = 88	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 revascularisation^a	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%)

*Significant p values ≤0.05 (two-tailed) are displayed
^aRevascularisation of any arteria in patient’s history, independently of the present diabetic foot ulcer infection

ISSN: 1471-2334