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Clinical Trials/NCT03939000
NCT03939000
Completed
Not Applicable

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

Udayana University0 sites113 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Foot Ulcer
Sponsor
Udayana University
Enrollment
113
Primary Endpoint
Age
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
January 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Udayana University
Responsible Party
Principal Investigator
Principal Investigator

Hendry Irawan

General Surgeon

Udayana University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • DFU patients without surgical intervention.

Outcomes

Primary Outcomes

Age

Time Frame: Before surgery

Age in years

Foot ulcer duration

Time Frame: Before surgery

Foot ulcer duration in weeks

Platelet

Time Frame: Before surgery

Platelet in 10\^9/L

Glycated hemoglobin

Time Frame: Before surgery

Glycated hemoglobin (HbA1c) in %

Serum creatinine

Time Frame: Before surgery

Serum creatinine in mg/dL

Prothrombin time

Time Frame: Before surgery

Prothrombin time (PT) in seconds

Gender

Time Frame: Before surgery

Gender is classified to male and female

Wagner classification

Time Frame: Before surgery

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

Neutrophil

Time Frame: Before surgery

Neutrophil in 10\^9/L

Lymphocyte

Time Frame: Before surgery

Lymphocyte in 10\^9/L

Random blood glucose

Time Frame: Before surgery

Random blood glucose in mg/dL

Serum potassium

Time Frame: Before surgery

Serum potassium in mmol/L

Diabetes mellitus duration

Time Frame: Before surgery

Diabetes mellitus duration in years

Leukocyte

Time Frame: Before surgery

Leukocyte in 10\^9/L

Blood urea nitrogen

Time Frame: Before surgery

Blood urea nitrogen (BUN) in mg/dL

International normalized ratio

Time Frame: 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

Time Frame: Before surgery

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

Surgical procedure

Time Frame: After surgery

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

Hemoglobin

Time Frame: Before surgery

Hemoglobin in g/dL

Hematocrit

Time Frame: Before surgery

Hematocrit in %

Alanine aminotransferase

Time Frame: Before surgery

Alanine aminotransferase (ALT) in U/L

Serum albumin

Time Frame: Before surgery

Serum albumin in g/dL

Basophil

Time Frame: Before surgery

Basophil in 10\^9/L

Eosinophil

Time Frame: Before surgery

Eosinophil in 10\^9/L

Monocyte

Time Frame: Before surgery

Monocyte in 10\^9/L

Aspartate aminotransferase

Time Frame: Before surgery

Aspartate aminotransferase (AST) in U/L

Serum sodium

Time Frame: Before surgery

Serum sodium in mmol/L

Activated partial thromboplastin time

Time Frame: Before surgery

Activated partial thromboplastin time (APTT) in seconds

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