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Topical Application of a Gentamicin-Collagen Sponge Combined with Systemic Antibiotic Therapy for the Treatment of Diabetic Foot Infections of Moderate Severity

A Randomized, Controlled, Multicenter Clinical Trial

Benjamin A. Lipsky Veterans Affairs Puget Sound Health Care System, University of Washington School of Medicine, Seattle, WA.

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Michael Kuss Premier Research Group Ltd, Austin, TX.

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Michael Edmonds King’s College Hospital, London, UK.

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Alexander Reyzelman Center for Clinical Research, Castro Valley, CA.

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Felix Sigal Pacific Clinical Center, Los Angeles, CA.

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Background:

The aim of this pilot study was to determine the safety and potential benefit of adding a topical gentamicin-collagen sponge to standard of care (systemic antibiotic therapy plus standard diabetic wound management) for treating diabetic foot infections of moderate severity.

Methods:

We randomized 56 patients with moderately infected diabetic foot ulcers in a 2:1 ratio to receive standard of care plus the gentamicin-collagen sponge (treatment group, n = 38) or standard of care only (control group, n = 18) for up to 28 days of treatment. Investigators performed clinical, microbiological, and safety assessments at regularly scheduled intervals and collected pharmacokinetic samples from patients treated with the gentamicin-collagen sponge. Test of cure was clinically assessed 14 days after all antibiotic therapy was stopped.

Results:

On treatment day 7, we noted clinical cure in no treatment patients and three control patients (P = .017). However, for evaluable patients at the test-of-cure visit, the treatment group had a significantly higher proportion of patients with clinical cure than did the control group (22 of 22 [100.0%] versus 7 of 10 [70.0%]; P =.024). Patients in the treatment group also had a higher rate of eradication of baseline pathogens at all visits (P ≤ .038) and a reduced time to pathogen eradication (P < .001). Safety data were similar for both groups.

Conclusions:

Topical application of the gentamicin-collagen sponge seems safe and may improve clinical and microbiological outcomes of diabetic foot infections of moderate severity when combined with standard of care. These pilot data suggest that a larger trial of this treatment is warranted. (J Am Podiatr Med Assoc 102(3): 223-232, 2012)

Corresponding author: Benjamin A. Lipsky, MD, Veterans Affairs Puget Sound Health Care System, S-111-PCC, 1660 S Columbian Way, Seattle, WA 98116-1597. (E-mail: balipsky@uw.edu)