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. 2021 Jan 19;10(2):371.
doi: 10.3390/jcm10020371.

Surgical Treatment of Diabetic Foot Ulcers Complicated by Osteomyelitis with Gentamicin-Loaded Calcium Sulphate-Hydroxyapatite Biocomposite

Kor H Hutting  1   2 , Wouter B Aan de Stegge  2   3 , Jaap J van Netten  1   3 , Wouter A Ten Cate  1 , Luuk Smeets  4 , Gijs M J M Welten  5 , Dick M Scharn  6 , Jean-Paul P M de Vries  2 , Jeff G van Baal  1   7
Affiliations

Surgical Treatment of Diabetic Foot Ulcers Complicated by Osteomyelitis with Gentamicin-Loaded Calcium Sulphate-Hydroxyapatite Biocomposite

Kor H Hutting et al. J Clin Med. .

Abstract

Diabetic foot ulcers, complicated by osteomyelitis, can be treated by surgical resection, dead space filling with gentamicin-loaded calcium sulphate-hydroxyapatite (CaS-HA) biocomposite, and closure of soft tissues and skin. To assess the feasibility of this treatment regimen, we conducted a multicenter retrospective cohort study of patients after failed conventional treatments. From 13 hospitals we included 64 patients with forefoot (n = 41 (64%)), midfoot (n = 14 (22%)), or hindfoot (n = 9 (14%)) ulcers complicated by osteomyelitis. Median follow-up was 43 (interquartile range, 20-61) weeks. We observed wound healing in 54 patients (84%) and treatment success (wound healing without ulcer recurrence) in 42 patients (66%). Treatment failures (no wound healing or ulcer recurrence) led to minor amputations in four patients (6%) and major amputations in seven patients (11%). Factors associated with treatment failures in univariable Cox regression analysis were gentamicin-resistant osteomyelitis (hazard ratio (HR), 3.847; 95%-confidence interval (CI), 1.065-13.899), hindfoot ulcers (HR, 3.624; 95%-CI, 1.187-11.060) and surgical procedures with gentamicin-loaded CaS-HA biocomposite that involved minor amputations (HR, 3.965; 95%-CI, 1.608-9.777). In this study of patients with diabetic foot ulcers, complicated by osteomyelitis, surgical treatment with gentamicin-loaded CaS-HA biocomposite was feasible and successful in 66% of patients. A prospective trial of this treatment regimen, based on a uniform treatment protocol, is required.

Keywords: diabetes mellitus; foot infections; foot ulcers; gentamicin-loaded calcium sulphate-hydroxyapatite biocomposite; osteomyelitis; surgery.

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Conflict of interest statement

All authors declare that they have no conflicting financial or non-financial interests regarding the subject matter or the materials discussed in this article. While conducting the data collection in this study, we contacted the only firm (iMove medical B.V., Nieuwegein, the Netherlands) that distributed gentamicin-loaded calcium sulphate-hydroxyapatite biocomposite in the Netherlands during the study period, to obtain a complete list of Dutch hospitals in which treatments with this material were performed. We used this information to make contacts with the treating physicians in these hospitals, without involvement of iMove medical B.V. No agreements were made with IMove Medical B.V., and this firm had no further involvement or control in this study whatsoever.

Figures

Figure 1
Figure 1
Surgical treatment with gentamicin-loaded calcium sulphate-hydroxyapatite (CaS-HA) biocomposite of a diabetic foot ulcer, complicated by osteomyelitis, at the medial aspect of the first metatarsophalangeal joint. (A) After surgical excision of the foot ulcer, macroscopic necrotic bone and necrotic and infected soft tissues are resected. (B) The dead space is irrigated with saline solution, and gentamicin-loaded CaS-HA biocomposite is injected. (C) The dead space is filled with gentamicin-loaded CaS-HA biocomposite. (D) In this dorsal-plantar x-ray image of the foot, the gentamicin-loaded CaS-HA biocomposite is visible as a density in the distal part of the metatarsal and the proximal phalanx (encircled).
Figure 2
Figure 2
Study flowchart. CaS-HA: Calcium sulphate-hydroxyapatite. DFO: Diabetic foot osteomyelitis. * Details of the surgical procedures are listed in Appendix A: Table A1.
Figure 3
Figure 3
Kaplan–Meier curve demonstrating treatment failures (persistent wounds or ulcer recurrence after initial postoperative wound healing) of surgical treatments with gentamicin-loaded calcium sulphate-hydroxyapatite biocomposite of diabetic foot ulcers complicated by osteomyelitis. Patients with persistent wounds are demonstrated as having an event at day 1. SE: Standard error.
Figure 4
Figure 4
Pathogens isolated in bone samples of 49 patients with diabetic foot ulcers complicated by osteomyelitis. (A) Distribution of pathogens isolated in 16 patients with monomicrobial osteomyelitis. (B) Distribution of 87 pathogens isolated in 33 patients with polymicrobial osteomyelitis. Gentamicin-resistance of pathogens was based on the minimal inhibitory concentration breakpoints of the European Committee on Antimicrobial Sensitivity Testing (EUCAST).
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