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临床试验/NCT03939000
NCT03939000已完成不适用

Clinical Profile and Laboratory Finding of Diabetic Foot Ulcers From Tertiary Hospitals in Bali

Udayana University0 个研究点目标入组 113 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
113
主要终点
Age

研究概览

简要总结

The investigators want to obtain the clinical profile, hematological profile, and biochemical profile from diabetic foot ulcer (DFU) patient.

详细描述

This study is a retrospective descriptive study reviewing the medical records of diabetic foot patients who were admitted to Sanglah General Hospital for surgical procedure. Sanglah General Hospital is a provincial hospital located in Denpasar, Bali, which is the central referral hospital in Bali and Nusa Tenggara islands as known as a tertiary hospital.

All DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre were included in the study. All patient medical records were provided by our hospital information center system. A diagnosis of diabetes mellitus was defined and confirmed from ICD (International Classification of Diseases)-10 code E11.622 for "Type 2 Diabetes Mellitus with other skin ulcers".

Data which we collected from the hospital information center system were further addressed into different aspects, which comprised of personal data, DFU severity, diabetes mellitus duration, ulcer duration, treatment procedures, and laboratory results. Based on our main objective of this study, we divide the laboratory results into two groups, hematological and blood chemistry profile. The variables selected in the hematological profile were hemoglobin, hematocrit, leukocyte and differential counts, and platelet. The variables which were included in blood chemistry profile are alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum albumin, random blood glucose, glycated hemoglobin (HbA1c), blood urea nitrogen (BUN), serum creatinine, serum sodium, serum potassium, prothrombin time (PTT), activated partial thromboplastin time (APTT), and international normalized ratio (INR).

The protocol of DFU management in our hospital included diagnosis and treatment of infection (local and systemic), assessment of patient's diabetic status, treatment of infection, diabetes mellitus, and wound care, and also surgical procedure, such as sharp debridement and amputations. The procedures were classified into five categories, consist of debridement, amputation of the fingers, transmetatarsal amputation, amputation below the knee, and amputation above the knee. DFU severity is classified into five different grades, based on Wagner's diabetic foot classification. In our hospital, patients with diabetic foot problems were evaluated and treated by a team consisting of surgeons, endocrinologists, microbiologists, rehabilitation specialists, nutritionists, and nurses.

For the statistical analyses, variables were assessed using the program IBM SPSS statistics version 23.0 for Windows (IBM Corporation, New York, USA). All numerical data were summarized as mean ± standard deviation, and categorical variables were summarized as frequency and percentage. Our method is about to use every available data to descriptively picture laboratory characteristics in DFU patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre.

排除标准

  • DFU patients without surgical intervention.

结局指标

主要结局

Age

时间窗: Before surgery

Age in years

Foot ulcer duration

时间窗: Before surgery

Foot ulcer duration in weeks

Platelet

时间窗: Before surgery

Platelet in 10\^9/L

Glycated hemoglobin

时间窗: Before surgery

Glycated hemoglobin (HbA1c) in %

Serum creatinine

时间窗: Before surgery

Serum creatinine in mg/dL

Prothrombin time

时间窗: Before surgery

Prothrombin time (PT) in seconds

Gender

时间窗: Before surgery

Gender is classified to male and female

Wagner classification

时间窗: Before surgery

Wagner classification is classified to grade 1, grade 2, grade 3, grade 4, and grade 5

Neutrophil

时间窗: Before surgery

Neutrophil in 10\^9/L

Lymphocyte

时间窗: Before surgery

Lymphocyte in 10\^9/L

Random blood glucose

时间窗: Before surgery

Random blood glucose in mg/dL

Serum potassium

时间窗: Before surgery

Serum potassium in mmol/L

Diabetes mellitus duration

时间窗: Before surgery

Diabetes mellitus duration in years

Leukocyte

时间窗: Before surgery

Leukocyte in 10\^9/L

Blood urea nitrogen

时间窗: Before surgery

Blood urea nitrogen (BUN) in mg/dL

International normalized ratio

时间窗: Before surgery

International normalized ratio (INR) has no units (it is a ratio) and is determined to decimal place. INR formula is (patient PT/mean normal PT)ISI. ISI stands for International Sensitivity Index

Foot affected

时间窗: Before surgery

Foot affected is classified to right foot, left foot, and bilateral

Surgical procedure

时间窗: After surgery

Surgical procedure is classified to debridement, finger amputation, transmetatarsal amputation, below the knee amputation, and above the knee amputation

Hemoglobin

时间窗: Before surgery

Hemoglobin in g/dL

Hematocrit

时间窗: Before surgery

Hematocrit in %

Alanine aminotransferase

时间窗: Before surgery

Alanine aminotransferase (ALT) in U/L

Serum albumin

时间窗: Before surgery

Serum albumin in g/dL

Basophil

时间窗: Before surgery

Basophil in 10\^9/L

Eosinophil

时间窗: Before surgery

Eosinophil in 10\^9/L

Monocyte

时间窗: Before surgery

Monocyte in 10\^9/L

Aspartate aminotransferase

时间窗: Before surgery

Aspartate aminotransferase (AST) in U/L

Serum sodium

时间窗: Before surgery

Serum sodium in mmol/L

Activated partial thromboplastin time

时间窗: Before surgery

Activated partial thromboplastin time (APTT) in seconds

次要结局

未报告次要终点

研究者

发起方
Udayana University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hendry Irawan

General Surgeon

Udayana University

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