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

Completed

• Conditions: Laboratory Problem; Physical Findings.Skin Ulcer; Diabetic Foot Ulcer; Type 2 Diabetes Mellitus

• Registration Number: NCT03939000
• Lead Sponsor: Udayana University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2018-12
• Study Completion: 2019-01
• Study First Submitted: 2019-04-30
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-02
• Last Update Submitted: 2019-05-02
• Study First Posted: 2019-05-06
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

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

Exclusion Criteria

• DFU patients without surgical intervention.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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