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临床试验/NCT02736253
NCT02736253已完成不适用

Determining of Independent Risk Factors for Three Critical Stages of the Diabetic Foot Infections Without Using the Well-known Classification Systems: Osteomyelitis, Amputation and Major Amputation

Ege University1 个研究点 分布在 1 个国家目标入组 379 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
379
试验地点
1
主要终点
The cases applied amputation(minor or major) and The cases applied major amputation

研究概览

简要总结

In this study, it was aimed to evaluate the independent risk factors for osteomyelitis, amputation and major amputation of the diabetic foot infection in the forward direction without using standard scoring procedures.

详细描述

In this study, it was aimed to evaluate the independent risk factors for osteomyelitis, amputation and major amputation of the diabetic foot infection in the forward direction without using standard scoring procedures. Patients who were applied to Diabetic Foot Council of our setting with diabetic foot infections between 2012 and 2014 were included in the study. Patients were followed prospectively and ethical approval was obtained from research ethics committee of our setting. An informed consent form was provided by each patient. Diabetic foot infection was decided as local infection involving only the skin and the subcutaneous tissue or infection involving symptoms and signs more than this criterion. Properties and variables of the cases were recorded during the admission process with total 57 different situations. The related characteristics were followed until the end of the treatment. Osteomyelitis, amputation and factors affecting to have major amputation on the cases were investigated. In the first step, data normality tests were performed with a simple data analysis and univariate analysis was applied in the second stage to which meaningful. At the last stage, major amputation, amputation and osteomyelitis were analyzed with stepwise multiple logistic analysis (SLA) model. Logistic regression was subject as significant data were saved as the independent risk factor. The Odds ratio and 95% CI were calculated from the beta coefficients of the variables with significant p value. P < 0.05 was used for significance at all tests.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteer to participate in research (An informed consent form was provided by each patient),
  • Patient with infected diabetic foot,
  • The lack of mental retardation or mental disorders

排除标准

  • The patient refused to participate in the study,
  • Age < 18 years.
  • Patient's opinion or participation in another clinical trial
  • The patient has previously been recruited to the study.
  • Another rapidly progressive or terminal illness.

结局指标

主要结局

The cases applied amputation(minor or major) and The cases applied major amputation

时间窗: within the first 3 months after admission

Transfemoral, transtibial, knee disarticulation, and hipdisarticulation amputations were decided as MAJOR AMPUTATION. Other amputation types(more than disarticulation) of lower extremity and major amputations decided as AMPUTATION

Evidence of clinically definite Osteomyelitis

时间窗: within the first 45 days after admission (hospitalization) (plus or minus 10 days)

Number of cases with osteomyelitis as assessed with using at least two of criteria below: X-ray graphic imaging, magnetic resonance imaging, bone tissue microbiological culture bone pathological biopsy Follow-up of patients was completed, after the wound healed. The healing was defined as the complete and uniform skin formation at the wound.

次要结局

  • To Decide Independent Risk factors for AMPUTATION and - for MAJOR AMPUTATION.(within the first 3 months after admission)
  • To Decide Independent Risk factors for osteomyelitis in patients with Diabetic Foot Infections(within the first 5±2 days after admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serhat Uysal

specialist medical doctor Serhat UYSAL

Ege University

研究点 (1)

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