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临床试验/CTRI/2023/09/058013
CTRI/2023/09/058013尚未招募不适用

Prospective observational study to assess risk factors leading to Amputation in Diabetic foot patients at a tertiary health care center in Belagavi

Dr Praveen Krishnan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To determine risk factors leading to amputation in diabetic foot patients.

研究概览

简要总结

Diabetes is  the  most common  underlying  cause of  foot ulcers,  infection  and  ischemia,  which are  among  the most serious  complications  of diabetes,  leading  to hospitalization  and the  most  frequent cause  of  non- traumatic  lower extremity  amputation. Despite well-defined risk factors for diabeticfoot ulcer development, limited data are available as to which factors predictamputation in a diabetic foot ulcer episode. There are numerous classification systems fordiabetic foot ulcer outcome prediction, but only few studies evaluated theirreliability and validity. Thus, asingle or simplified classification system, which includes the most accuratepredictive factors for amputation, would facilitate decision-making. Therefore, topredict lower limb  amputation  occurrence and  to determine  the  factors associated  with  the risk  of amputation in diabetic footpatients, we conducted this study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Diabetic patients with written and informed consent, of either sex with foot infections defined as infection of soft tissue in diagnosed case of diabetes mellitus with or without treatment and newly- diagnosed diabetics.

排除标准

  • Patients with history of previous amputations -Those suffering from HIV,HBSAg,HCV positivity, psychiatry disorders -Pregnant and lactating females -Patients receiving immunosuppressive therapy and radiotherapy.

结局指标

主要结局

To determine risk factors leading to amputation in diabetic foot patients.

时间窗: 1 Year

次要结局

  • To predict lower limb amputation occurrence(1 Year)

研究者

发起方
Dr Praveen Krishnan
申办方类型
Other [self-funded]

研究点 (1)

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