The effectiveness of systemic antibiotics for osteomyelitis of the foot in adults with diabetes mellitus: a systematic review protocol

Abstract

Background Osteomyelitis of the foot is a major complication of diabetes that can be limb and life threatening. Systemic antibiotic pharmacotherapy is often used first line to eradicate infection and allow restoration of devitalised bone. The aim is to conduct a systematic review of the effectiveness of systemic antibiotics on osteomyelitis of the foot in adults with diabetes mellitus. Methods A systematic review of all interventional studies treating osteomyelitis with systemic antibiotics in participants with diabetes mellitus and an ulcer of the foot below the malleoli will be conducted. Studies not available in English and in people below the age of 18 will be excluded. Study selection will follow the Patient Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA-P guidelines). The quality of the studies will be assessed using the Cochrane risk-of-bias tool (RoB 2) for all randomised controlled trials and the Newcastle–Ottawa Scale (NOS) will be used for non-randomised controlled trials. Electronic databases will be searched with no timeline restrictions. Data Extraction All identified references will be imported to the Rayyan Application. Studies for eligibility will be screened by two reviewers. One reviewer will perform the data extraction and quality appraisal will be conducted by two authors. If sufficient data is available, the quality will be analysed and a meta-analysis will be performed. Data synthesis will be conducted, and meta-analysis undertaken using RevMan 5.4.1 Meta-analysis software. Non-parametric data may be compared between selective intervention and outcomes. Discussion The results of this systematic review will identify the effectiveness of systemic antibiotic therapy on osteomyelitis of the foot in people with diabetes based on the set outcome measure criteria. The findings will establish if there are existing consistent standards or variation in practice when treating diabetic foot osteomyelitis (DFO). The study may establish if guidelines are required to standardise practice when treating DFO with systemic antibiotic therapy. This systematic review protocol will synthesise the existing evidence on the effectiveness of systemic antibiotic therapy for treating DFO. Trial registration International Prospective Register for Systematic Reviews (PROSPERO) number CRD42021245424.