Clinical trial NCT03939000: Clinical Profile and Laboratory Finding of DFU From Tertiary Hospitals in Bali
Official title: Clinical Profile and Laboratory Finding of Diabetic Foot Ulcers From Tertiary Hospitals in Bali
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Type 2 Diabetes Mellitus
Laboratory Problem
Physical Findings.Skin Ulcer
Keywords: clinical profile
diabetic foot ulcer
laboratory finding
tertiary hospital
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* DFU patients without surgical intervention.

Primary outcomes:
measure: Age
timeFrame: Before surgery
measure: Diabetes mellitus duration
timeFrame: Before surgery
measure: Foot ulcer duration
timeFrame: Before surgery
measure: Gender
timeFrame: Before surgery
measure: Foot affected
timeFrame: Before surgery
measure: Wagner classification
timeFrame: Before surgery
measure: Surgical procedure
timeFrame: After surgery
measure: Hemoglobin
timeFrame: Before surgery
measure: Hematocrit
timeFrame: Before surgery
measure: Leukocyte
timeFrame: Before surgery
measure: Basophil
timeFrame: Before surgery
measure: Eosinophil
timeFrame: Before surgery
measure: Neutrophil
timeFrame: Before surgery
measure: Lymphocyte
timeFrame: Before surgery
measure: Monocyte
timeFrame: Before surgery
measure: Platelet
timeFrame: Before surgery
measure: Alanine aminotransferase
timeFrame: Before surgery
measure: Aspartate aminotransferase
timeFrame: Before surgery
measure: Serum albumin
timeFrame: Before surgery
measure: Random blood glucose
timeFrame: Before surgery
measure: Glycated hemoglobin
timeFrame: Before surgery
measure: Blood urea nitrogen
timeFrame: Before surgery
measure: Serum creatinine
timeFrame: Before surgery
measure: Serum sodium
timeFrame: Before surgery
measure: Serum potassium
timeFrame: Before surgery
measure: Prothrombin time
timeFrame: Before surgery
measure: Activated partial thromboplastin time
timeFrame: Before surgery
measure: International normalized ratio
timeFrame: Before surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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