跳至主要内容
临床试验/CTRI/2021/01/030653
CTRI/2021/01/030653尚未招募不适用

Serum Biomarkers Procalcitonin and d-dimer in Diabetic Foot

Lady Hardinge Medical College1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Levels of Biomarkers Procalcitonin and d-dimer among the patients of Diabetic Foot Ulcer

研究概览

简要总结

Aim of the study is to evaluate the levels of plasma, procalcitonin and d-dimer in patients with diabetic foot ulcer and correlate the same with the grade of diabetic foot ulcer.

After ethics approval andregistration on CTRI, all patients in the age group of 18 to 65 years withdiabetic foot ulcer in Lady Hardinge Medical College and associatedhospitals shall be considered for inclusion. Written informed consent willbe taken from patients. Blood samples will be collected in all patients.Reports will be evaluated and analysed. All demographic data will be recordedin a predesigned form.

 Blood samples for serumbiomarkers Procalcitonin and D dimer will be collected from all patients takingall aseptic precautions. Procalcitonin will be processed by spectrophotometricmethod by fully automated analysers (Beckman series) by respective kit. D-dimerwill be processed by ELISA method (Enzyme linked immunosorbent assay). Allother relevant investigations will be done as per proforma.

Biomarkerswill be correlated with the different grades of Diabetic Foot Ulcer accordingto the Meggitt-Wagnersystem of classification. [20]

Grade -0

Healed or pre-ulcerative wound

|Grade-1

Superficial ulcer without penetrating to deeper layers

|Grade-2

Deeper ulcer and reaches tendon, bone or joint capsule

|Grade-3

Deeper tissues are involved and there is abscess formation, osteomyelitis or tendinitis

|Grade -4

Limited Gangrene(part of the foot)

|Grade-5

Whole foot gangrene

 The reports ofserum biomarkers will be collected and correlated.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All new patients of any sex with 18 to 65 years of age with type 2 diabetes mellitus with diabetic foot ulcer in Lady Hardinge Medical College and associated hospitals.

排除标准

  • Any patient who has received any antibiotics in last seven days.
  • Patients with other known site of infection.

结局指标

主要结局

Levels of Biomarkers Procalcitonin and d-dimer among the patients of Diabetic Foot Ulcer

时间窗: Baseline Levels at presentation

次要结局

  • Grade of Diabetic Foot Ulcer and it’s correlation with Levels of Biomarkers.(Baseline At presentation)

研究者

申办方类型
Government medical college

研究点 (1)

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Biomarkers in diabetic foot | 临床试验