A team of researchers has published a protocol for a systematic review and network meta-analysis that will determine the safest and most effective duration of systemic antibiotic therapy in patients with diabetic foot osteomyelitis managed without amputation. The initiative seeks to resolve longstanding uncertainty around treatment timelines and the risks associated with prolonged antibiotic use.
The protocol, registered in PROSPERO (CRD42023486089), outlines plans for a comprehensive search of studies published through January 1, 2027.
Diabetic foot osteomyelitis (DFO) complicates approximately 20% of infected diabetic foot ulcers and significantly increases the risk of limb amputation and mortality. Although surgery is sometimes required, many cases are successfully managed with systemic antibiotics. However, the optimal treatment duration remains unclear.
While current guidelines from the International Working Group on the Diabetic Foot/Infectious Diseases Society of America recommend limiting antibiotic treatment to 6 weeks, some clinicians extend therapy to improve infection control. Small randomized trials have reported similar remission rates with 3- and 6-week regimens, but limited sample sizes have prevented firm conclusions.
The planned review will synthesize findings from randomized controlled trials comparing different durations of systemic antibiotic therapy in adults with DFO managed without amputation. Researchers will assess remission rates, time to complete wound healing, rates of major amputation, and antibiotic-related adverse events. Only studies using imaging, microbiological, or histologic criteria to diagnose DFO will be included.
The study will include participants aged 18 years and older with confirmed diabetes and DFO diagnosis. Both oral and intravenous antibiotic regimens will be analyzed, including empirical and targeted therapies. Interventions involving any form of amputation will be excluded.
Researchers will define remission as the absence of recurrent or persistent infection at the original site, supported by radiographic stabilization and clinical assessment. Researchers will also consider avoidance of surgical intervention at the affected site during follow-up a marker of treatment success.
Researchers will search multiple databases, including the China National Knowledge Infrastructure, VIP database, Wanfang Data, ScienceDirect, EBSCO, EMBASE, Web of Science, Cochrane Library, and PubMed.
Data will be analyzed using both pairwise and network meta-analyses. Network meta-analysis will be performed using STATA/MP V.15.0 software, with treatments ranked for efficacy and safety using surface under the cumulative ranking area. Sensitivity analyses will be conducted if substantial heterogeneity is detected, and publication bias will be assessed using funnel plots.
Researchers will also examine whether factors such as age, sex, wound type, infection site, and antibiotic class influence outcomes. The strength of evidence for each outcome will be graded using the GRADE framework.
To improve generalizability, the review will include studies published in both English and Chinese. The goal of the project is to support evidence-based decision-making around antibiotic duration for a common and burdensome complication of diabetes.
The authors plan to publish their findings in a peer-reviewed journal. No conflicts of interest were reported.
Source: BMJ Open