Consistency of microbiological and pathological tests between infected bone and surrounding deep soft tissues in diabetic foot osteomyelitis: study protocol for a single-center, self- controlled, open-lael trial

<div><b>Abstract</b></div><div><b>Background: </b>Diabetic foot osteomyelitis is a mixed bone infection, and early detection and treatment can avoid unnecessary amputation and improve patient survival. However, determining an accurate diagnosis is a difficult and commonly encountered challenge. Most patients fail to exhibit any overt symptoms or hematological characteristics despite the presence of a severe limb infection. The most commonly</div><div>used clinical standard for diagnosis is histological and microbiological examination of the bone tissue. However, such examinations are not feasible in all patients suspected to have diabetic foot osteomyelitis, and many affected patients have an insufficient understanding of the need to repeatedly collect bone samples and thus exhibit poor compliance. Further, the proper use of antibiotics in the treatment of diabetic foot osteomyelitis is severely hampered by the difficulty of diagnosis. Considering that patients often develop soft tissue infection followed by bone infection, we assume that the histological and microbiological findings of bone tissue are consistent with those of the deep soft tissue around the bone infection. In this study, we will explore whether deep soft tissue specimens are an alternative to bone tissue specimens in histological and micrAbstractAbstractobiological tests for the clinical diagnosis of diabetic foot osteomyelitis.</div><div><b>Methods/Design: </b>A prospective, single-center, self-controlled, open-label trial will be completed at Tianjin Metabolic Diseases Hospital of Tianjin Medical University in China. A total of 200 patients with diabetic foot osteomyelitis, aged 18 to 80 years, of both sexes, and admitted as outpatients from 12 March 2015 will be recruited and subjected to histological and microbiological examinations of infected bone and surrounding deep soft tissue. The primary outcome will be the sensitivity and specificity of microbial cultures of infected bone and surrounding deep soft tissue at admission for diabetic foot osteomyelitis. The secondary outcomes will be blood</div><div>biochemical indices, X-ray characteristics of the affected foot, and the blood supply of the affected lower limb. Findings from the microbial cultures of bone and deep soft tissue will be used to calculate the positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for the diagnosis of diabetic foot osteomyelitis. We will therefore be able to verify</div><div>whether the histological and microbiological tests exhibit consistent results between infected bone and surrounding deep soft tissue.</div><div><b>Discussion: </b>Findings from this trial will provide new insight into the early diagnosis and proper use of antibiotics based on repeated diagnoses in patients with diabetic foot osteomyelitis.</div><div><b>Trial registration: </b>This protocol was registered at Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-10001079) on 6 September 2010.</div><div><b>Ethics: </b>Written approval for this trial was obtained from the Ethics Committee of the Tianjin Metabolic Diseases Hospital, Tianjin Medical University of China (approval No. DXBXYhMEC2015-7).<b> </b>This study will be performed in accordance with the guideAbstract</div><div><b>Background: </b>Diabetic foot osteomyelitis is a mixed bone infection, and early detection and treatment can avoid unnecessary amputation</div><div>and improve patient survival. However, determining an accurate diagnosis is a difficult and commonly encountered challenge. Most patients fail to exhibit any overt symptoms or hematological characteristics despite the presence of a severe limb infection. The most commonly used clinical standard for diagnosis is histological and microbiological examination of the bone tissue. However, such examinations are not feasible in all patients suspected to have diabetic foot osteomyelitis, and many affected patients have an insufficient understanding of the need to repeatedly collect bone samples and thus exhibit poor compliance. Further, the proper use of antibiotics in the treatment of</div><div>diabetic foot osteomyelitis is severely hampered by the difficulty of diagnosis. Considering that patients often develop soft tissue infection followed by bone infection, we assume that the histological and microbiological findings of bone tissue are consistent with those of the deep soft tissue around the bone infection. In this study, we will explore whether deep soft tissue specimens are an alternative to bone tissue specimens in histological and microbiological tests for the clinical diagnosis of diabetic foot osteomyelitis.lines of the Declaration of Helsinki, formulated by the World Medical Association.</div><div><b>Informed consent:</b> Written informed consent will be obtained from each participant.</div><div><b><br></b></div><div><b>Key words: </b>clinical trial; diabetic foot osteomyelitis; bone; soft tissue; microbial cultures; pathological examination; correlation;sensitivity; specificity; self-controlled open trial</div><div><b><br></b></div><div><b>doi:</b>10.4103/2468-5674.183004</div><div><b>How to cite this article: </b>Xu J, Wang PH, Li XM, Feng SH, Ding M, Li XW, Yao WJ, Zhao ZX (2016) Consistency of microbiological and pathological tests between infected bone and surrounding deep soft tissues in diabetic foot osteomyelitis: study protocol for a single-center, self-controlled, open-lael trial. Clin Transl Orthop 1(2):0-0.