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

Abstract

Background: An adjunctive topical therapy with gentamicin-sponges to systemic antibiotic therapy might improve the healing of infected diabetic foot ulcers (DFUI).

Methods: Single-center, investigator-blinded pilot study, randomizing (1:1) the gentamicin-sponge with systemic antibiotic versus systemic antibiotics alone for patients with DFUI.

Results: We included 88 DFUI episodes with 43 patients in the gentamicin-sponge arm and 45 in the control arm. Overall, 64 (64/88; 73%) witnessed total clinical cure, 13 (15%) significant improvement, and 46 (52%) showed total eradication of all pathogens at the final visit. Regarding final clinical cure, there was no difference in favour of the gentamicin-sponges (26/45 vs. 31/43; p = 0.16). However, the gentamicin-sponge arm tended to a more rapid healing. In multivariate analysis adjusting for the case-mix, the variable "gentamicin-sponge" was not significantly associated with "cure and improvement". Gentamicin-sponges were very well tolerated, without any attributed adverse events.

Conclusions: The gentamicin-sponge was very well tolerated, but did not significantly influence overall cure.

Trial registration: ClinicalTrials.gov ( NCT01951768 ). Date 2 April 2013.

Keywords: Cure; Diabetic foot infections; Gentamicin sponge; Pathogens; Safety.

Conflict of interest statement

The local Ethics Committee of Geneva Canton approved our study (number 13–039). Diabetologists, orthopaedic surgeons, podiatrists, infectious diseases physicians, reeducation specialists, and many internists were informed about this study. Theses colleagues informed the investigators whenever they encountered patients with diabetic foot infections or diabetic foot ulcers. The study team orally informed eligible patients about the possibility of participating in this study. Upon interest, the patients read and signed the consent letter (in French language). Thus, the consent to participate was always written and signed by the patients themselves. The patients had enough time (several hours until two days) to read or discuss the consent letter either with their family, the nursing team, the physicians, and finally always with the study team. The participating patients were followed-up by the study team.

The local Ethics Committee of Geneva Canton consented for publication. Regarding the Figs. 3, 1, and 2, as well as the Additional file 2: Video S1, all photographed persons signed a written consent. They are all alive at the revision of this manuscript. Besides for the Additional file 2: Video S1, we avoided the photograph the face. The “doctor” or “nurse” on the Additional file 2: Video S1 is the second author of this manuscript (Additional file 2).

A.T., S.M., D.L., and B.K. declare no conflict of interest. B.A.L. has served as a consultant to Innocoll, Forest, Cubist, Merck, and Pfizer. I.U. has received an unconditional research donation from Innocoll.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1

Local infection and ulcer not requiring surgery. Included in study. Photo permitted by patient

Fig. 2

Diabetic foot necrosis with underlying abscess requiring amputation. Excluded from study. Photo permitted by patient

Fig. 3

Putting the sponge on the wound. Educational photo with the permission of the patient

Fig. 4

Flowchart of the study inclusion

Fig. 5

Median wound scores over 6 weeks stratified by study arms