Our analysis found no threshold for the optimal duration or route of administration of antibiotic therapy to prevent recurrences of DFI. These limited data might support possibly shorter treatment duration for patients with DFI.

BackgroundAn adjunctive topical therapy with gentamicin-sponges to systemic antibiotic therapy might improve the healing of infected diabetic foot ulcers (DFUI).MethodsSingle-center, investigator-blinded pilot study, randomizing (1:1) the gentamicin-sponge with systemic antibiotic versus systemic antibiotics alone for patients with DFUI.ResultsWe 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.ConclusionsThe gentamicin-sponge was very well tolerated, but did not significantly influence overall cure.Trial registrationClinicalTrials.gov (NCT01951768). Date 2 April 2013.Electronic supplementary materialThe online version of this article (10.1186/s12879-018-3253-z) contains supplementary material, which is available to authorized users.

Objectives:The initial phase of infection of a foot ulcer in a person with diabetes is often categorized as mild. Clinicians usually treat these infections with antimicrobial therapy, often applied topically. Some experts, however, believe that mild diabetic foot ulcer infections will usually heal with local wound care alone, without antimicrobial therapy or dressings.Methods:To evaluate the potential benefit of treatment with a topical antibiotic, we performed a single-center, investigator-blinded pilot study, randomizing (1:1) adult patients with a mild diabetic foot ulcer infection to treatment with a gentamicin–collagen sponge with local care versus local care alone. Systemic antibiotic agents were prohibited.Results:We enrolled a total of 22 patients, 11 in the gentamicin–collagen sponge arm and 11 in the control arm. Overall, at end of therapy, 20 (91%) patients were categorized as achieving clinical cure of infection, and 2 (9%) as significant improvement. At the final study visit, only 12 (56%) of all patients achieved microbiological eradication of all pathogens. There was no difference in either clinical or microbiological outcomes in those who did or did not receive the gentamicin–collagen sponge, which was very well tolerated.Conclusion:The results of this pilot trial suggest that topical antibiotic therapy with gentamicin–collagen sponge, although very well tolerated, does not appear to improve outcomes in mild diabetic foot ulcer infection.

Background In patients with diabetic foot osteomyelitis (DFO) who underwent surgical debridement, we investigated whether a short (3 weeks), compared with a long (6 weeks) duration of systemic antibiotic treatment is associated with non-inferior results for clinical remission and adverse events (AE). Methods In this prospective, randomized, non-inferiority, pilot trial, we randomized (allocation 1:1), patients with DFO after surgical debridement to either a 3-week or a 6-week course of antibiotic therapy. The minimal duration of follow-up after end of therapy was two months. We compared outcomes using Cox regression and non-inferiority analyses (25% margin, power 80%). Results Among 93 enrolled patients (18% females; median age 65 years), 44 were randomized to the 3-week arm and 49 to the 6-week arm. The median number of surgical debridement was 1 (range, 0-2 interventions). In the intention-to-treat (ITT) population, remission occurred in 37 (84%) of the patients in the 3-week arm compared to 36 (73%) in the 6-week arm (p=0.21). The number of AE was similar in the two study arms (17/44 vs. 16/49; p=0.51), as were the remission incidences in the per-protocol (PP) population (33/39 vs. 32/43; p=0.26). In multivariate analysis, treatment with the shorter antibiotic course was not significantly associated with remission (for the ITT population, hazard ratio 1.1, 95%CI 0.6-1.7; for the PP population hazard ratio 0.8, 95%CI 0.5-1.4). Conclusions In this randomized, controlled pilot trial, a post-debridement systemic antibiotic therapy course for DFO of 3-weeks gave similar (and statistically non-inferior) incidences of remission and AE to a course of 6 weeks.

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Aim: To assess amoxicillin-clavulanate (AMC) for the oral therapy of diabetic foot infections (DFIs), especially for diabetic foot osteomyelitis (DFO). Methods:We performed a retrospective cohort analysis among 794 DFI episodes, including 339 DFO cases. Results:The median duration of antibiotic therapy after surgical debridement (including partial amputation) was 30 days (DFO, 30 days). Oral AMC was prescribed for a median of 20 days (interquartile range, 12-30 days). The median ratio of oral AMC among the entire antibiotic treatment was 0.9 (interquartile range, 0.7-1.0). After a median follow-up of 3.3 years, 178 DFIs (22%) overall recurred (DFO, 75; 22%). Overall, oral AMC led to 74% remission compared with 79% with other regimens (χ 2 -test; P = 0.15). In multivariate analyses and stratified subgroup analyses, oral AMC resulted in similar clinical outcomes to other antimicrobial regimens, when used orally from the start, after an initial parenteral therapy, or when prescribed for DFO.Conclusions: Oral AMC is a reasonable option when treating patients with DFIs and DFOs. K E Y W O R D Samoxillin-clavunalate, diabetic foot infections, failures, oral β-lactams, osteomyelitis

After the successful treatment of a DFI, recurrent episodes are frequent. A history of a previous DFI episode did not predict a greater likelihood of any antibiotic-resistant isolate in subsequent episodes. Thus, broadening the spectrum of empiric antibiotic therapy for recurrent episodes of DFI does not appear necessary.

Summary Objective The appropriate duration of antibiotic therapy for diabetic foot infections (DFI) after surgical amputations in toto is debated. There are discrepancies worldwide. Methods Using a clinical pathway for adult DFI patients (retrospective cohort analysis), we conducted a cluster‐controlled Cox regression analysis. Minimum follow‐up was 2 months. Results We followed 482 amputated DFI episodes for a median of 2.1 years after the index episode. The DFIs predominately affected the forefoot (n = 433; 90%). We diagnosed osteomyelitis in 239 cases (239/482; 50%). In total, 47 cases (10%) were complicated by bacteremia, 86 (18%) by abscesses and 139 (29%) presented with cellulitis. Surgical amputation involved the toes (n = 155), midfoot (280) and hindfoot (47). Overall, 178 cases (37%) required revascularization. After amputation, the median duration of antibiotic administration was 7 days (interquartile range, 1‐16 days). In 109 cases (25%), antibiotics were discontinued immediately after surgery. Overall, clinical failure occurred in 90 DFIs (17%), due to the same pathogens in only 38 cases. In multivariate analysis, neither duration of total postsurgical antibiotic administration (HR 1.0, 95% CI 0.99‐1.01) nor immediate postoperative discontinuation altered failure rate (HR 0.9, 0.5‐1.5). Conclusion According to our clinical pathway, we found no benefit in continuing postsurgical antibiotic administration in routine amputation for DFI. In the absence of residual infection (ie, resection at clear margins), antibiotics should be discontinued.