Clinical Profile and Laboratory Finding of DFU From Tertiary Hospitals in Bali

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

Detailed Description
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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.

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

Conditions
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Diabetic Foot Ulcer, Type 2 Diabetes Mellitus, Laboratory Problem, Physical Findings.Skin Ulcer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre. Exclusion Criteria: DFU patients without surgical intervention.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age in years | Before surgery | 
| Diabetes mellitus duration | Diabetes mellitus duration in years | Before surgery | 
| Foot ulcer duration | Foot ulcer duration in weeks | Before surgery | 
| Gender | Gender is classified to male and female | Before surgery | 
| Foot affected | Foot affected is classified to right foot, left foot, and bilateral | Before surgery | 
| Wagner classification | Wagner classification is classified to grade 1, grade 2, grade 3, grade 4, and grade 5 | Before surgery | 
| Surgical procedure | Surgical procedure is classified to debridement, finger amputation, transmetatarsal amputation, below the knee amputation, and above the knee amputation | After surgery | 
| Hemoglobin | Hemoglobin in g/dL | Before surgery | 
| Hematocrit | Hematocrit in % | Before surgery | 
| Leukocyte | Leukocyte in 10^9/L | Before surgery | 
| Basophil | Basophil in 10^9/L | Before surgery | 
| Eosinophil | Eosinophil in 10^9/L | Before surgery | 
| Neutrophil | Neutrophil in 10^9/L | Before surgery | 
| Lymphocyte | Lymphocyte in 10^9/L | Before surgery | 
| Monocyte | Monocyte in 10^9/L | Before surgery | 
| Platelet | Platelet in 10^9/L | Before surgery | 
| Alanine aminotransferase | Alanine aminotransferase (ALT) in U/L | Before surgery | 
| Aspartate aminotransferase | Aspartate aminotransferase (AST) in U/L | Before surgery | 
| Serum albumin | Serum albumin in g/dL | Before surgery | 
| Random blood glucose | Random blood glucose in mg/dL | Before surgery | 
| Glycated hemoglobin | Glycated hemoglobin (HbA1c) in % | Before surgery | 
| Blood urea nitrogen | Blood urea nitrogen (BUN) in mg/dL | Before surgery | 
| Serum creatinine | Serum creatinine in mg/dL | Before surgery | 
| Serum sodium | Serum sodium in mmol/L | Before surgery | 
| Serum potassium | Serum potassium in mmol/L | Before surgery | 
| Prothrombin time | Prothrombin time (PT) in seconds | Before surgery | 
| Activated partial thromboplastin time | Activated partial thromboplastin time (APTT) in seconds | Before surgery | 
| International normalized ratio | 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 | Before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical profile, diabetic foot ulcer, laboratory finding, tertiary hospital