Clinical Profile and Laboratory Finding of Diabetic Foot Ulcers From Tertiary Hospitals in Bali
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
- 否
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
Hendry Irawan
General Surgeon
Udayana University
