BACKGROUND Few studies have addressed the appropriate duration of antibiotic therapy for diabetic foot infections (DFI) with or without amputation. We will perform two randomized clinical trials (RCTs) to reduce the antibiotic use and associated adverse events in DFI. METHODS We hypothesize that shorter durations of postdebridement systemic antibiotic therapy are noninferior (10% margin, 80% power, alpha 5%) to existing (long) durations and we will perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCTs is remission of infection after a minimal follow-up of 2 months. The secondary outcomes for both RCTs are the incidence of adverse events and the overall treatment costs. The first RCT will allocate the total therapeutic amputations in two arms of 50 patients each: 1 versus 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 versus 4 days for remaining soft tissue infection. The second RCT will randomize the conservative approach (only surgical debridement without in toto amputation) in two arms with 50 patients each: 10 versus 20 days of antibiotic therapy for soft tissue infections; and 3 versus 6 weeks for osteomyelitis. All participants will have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, podiatric, internist and infectiology care. During the surgeries, we will collect tissues for BioBanking and future laboratory studies. DISCUSSION Both parallel RCTs will respond to frequent questions regarding the duration of antibiotic use in the both major subsets of DFIs, to ensure the quality of care, and to avoid unnecessary excesses in terms of surgery and antibiotic use. TRIAL REGISTRATION ClinicalTrials.gov, NCT04081792. Registered on 4 September 2019.

中文翻译：

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糖尿病足感染抗生素管理的优化：两项随机对照试验的方案。

背景技术很少有研究针对有或没有截肢的糖尿病足感染（DFI）抗生素治疗的适当持续时间。我们将进行两项随机临床试验（RCT），以减少DFI中抗生素的使用和相关的不良事件。方法我们假设清创后全身抗生素治疗的较短持续时间不逊于现有（较长）持续时间（10％裕度，80％功效，α5％），并且我们将进行两项无盲RCT，总共进行400次DFI发作（随机1： 1）从2019年到2022年。这两个RCT的主要结局是经过至少2个月的随访后感染缓解。两种随机对照试验的次要结果是不良事件的发生率和总体治疗费用。第一个RCT将把总的截肢手术分配给两个小组，每个小组50名患者：残余骨髓炎（残余骨残端的阳性微生物样本）用抗生素治疗1到3周；剩下的软组织感染需要1天或4天。第二项随机对照试验将在两组各有50例患者的两组中随机分配保守治疗方法（仅进行手术清创术而无须截肢术）：软组织感染的抗生素治疗时间为10天与20天；骨髓炎分别为3周和6周。所有参与者都将接受专业的伤口清创术，适当的负荷减轻，血管学评估以及相应的外科，再教育，足病，内科和感染学护理。在手术期间，我们将收集组织用于生物银行和将来的实验室研究。讨论两个并行的RCT都会回答有关DFI的两个主要亚类中抗生素使用持续时间的常见问题，以确保护理质量，并避免在手术和抗生素使用方面不必要的过度。试验注册ClinicalTrials.gov，NCT04081792。于2019年9月4日注册。