Inflammatory Biomarkers to Diagnose and Monitor Diabetic Foot Osteomyelitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 455
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of biomarkers to diagnose diabetic foot osteomyelitis using bone culture and histopathology as the "gold standard" to establish the diagnosis.
研究概览
简要总结
The investigators plan to do a retrospective chart review of 500 patients admitted to the hospital between January 1, 2010 and December 31, 2015 with diabetic foot infections. The investigators will define a positive case of osteomyelitis as bone with positive bacterial cultures or histologic finding of acute or chronic osteomyelitis. Levels of inflammatory biomarkers (CRP, ESR) will be collected from the charts from the first time of diagnosis. Because wound healing, biomarker levels and resolution of infection are clearly affected by other factors such as demographics, medical/surgical history, social history, medications, laboratory results, peripheral arterial disease, wound severity, and treatment factors such as type of antibiotics, off-loading, debridement and vascular surgery interventions these will also be collected. The investigators will collect this clinical data for both cohorts.
详细描述
Introduction and Purpose:
Foot infections are one of the most common reasons for hospitalization and amputation in persons with diabetes. It is often difficult to determine if diabetic foot ulcers have osteomyelitis. Inaccurate diagnosis of osteomyelitis leads to unnecessary antibiotic treatment, surgery, and amputation. In addition, there are no good diagnostic tests to determine when osteomyelitis has been successfully treated. The results of medical treatment for DFO alone are poor with success rates of 60%.
The investigators plan a retrospective chart review of 500 patients admitted to our hospital between January 1, 2010 and December 31, 2015 with diabetic foot infections. We will define diabetic foot osteomyelitis as bone with positive bacterial cultures or histologic finding of acute or chronic osteomyelitis.
The investigators also plan to review 200 foot infections in non-diabetics.
Specific Aims Aim 1. Evaluate the effectiveness of biomarkers to diagnose diabetic foot osteomyelitis using bone culture and histopathology as the "gold standard" to establish the diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of the investigators.
- •Male and female
- •ages 18-89
- •moderate diabetic foot infections (according to IDSA criteria) and non-diabetic foot infections who presented for treatment between January 1, 2010 and December 31,
- •positive case of osteomyelitis as bone with positive bacterial cultures or histologic finding of acute or chronic osteomyelitis.
- •The investigators will only enroll patients who have an initial baseline CRP or ESR within 72 hours of admission, before any surgical procedures.
排除标准
- •Not meeting inclusion criteria.
结局指标
主要结局
Evaluate the effectiveness of biomarkers to diagnose diabetic foot osteomyelitis using bone culture and histopathology as the "gold standard" to establish the diagnosis.
时间窗: 2 years
To correlate the level of white blood cell count, c-reactive protein and erythrocyte sedimentation rate with the results of bone culture and histopathology as the "gold standard" to establish the diagnosis.
Evaluate the effectiveness of biomarkers to differentiate osteomyelitis from deep soft tissue infections in patients with diabetic foot ulcers.
时间窗: 2 years
To correlate the accuracy of white blood cell count, c-reactive protein and erythrocyte sedimentation rate to differentiate osteomyelitis by observing the results of bone culture and histopathology as the "gold standard" to establish the diagnosis.
次要结局
未报告次要终点
研究者
Larry Lavery
Professor, Plastic Surgery; Principal Investigator
University of Texas Southwestern Medical Center