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临床试验/CTRI/2026/04/108178
CTRI/2026/04/108178尚未招募不适用

Comparative analysis of four systems of classification of diabetic foot ulcers in predicting lower extremity amputation (LEA) rate

Kasturba Medical College Manipal1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2026年4月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
108
试验地点
1

研究概览

简要总结

Patients with diabetic foot ulcer who meet the eligibility criteria presenting to the Kasturba Hospital Surgery OPD or admitted as in-patients will be recruited into the study. Detailed clinical examination will be performed and data will be collected using a proforma, including patient demographic details, history of diabetes, ulcer history and clinical examination findings. Baseline characteristics of the ulcer will be recorded. On the basis of the clinical examination, the ulcer will be staged under the four classifications intended to be compared. The patient will be followed up after one month telephonically to assess the outcome of each case, primarily in the form of lower extremity amputation and secondarily as need for debridement, development of sepsis and need for ICU stay.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Adult patients diagnosed with Type 1 or Type 2 Diabetes Mellitus with diabetic foot ulcer, visiting the Surgery OPD or admitted in wards
  • All diabetic foot ulcers irrespective of duration and presence of infection, peripheral vascular disease, diabetic neuropathy
  • Ability to consent and participate in the study.

排除标准

  • Diabetic individuals with ulcers above ankle
  • Patients with prior major lower extremity amputation, those with pre-existing below knee or above knee amputations
  • Participants who are lost to follow up or whose outcomes are unknown
  • Patients with cognitive impairments who cannot provide informed consent.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Poojary Yasha Babu

Kasturba Medical College, Manipal

研究点 (1)

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