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

NCT ID: NCT03939000

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 113 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-01-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• DFU patients without surgical intervention.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Udayana University

OTHER

Sponsor Role: lead

Responsible Party

Hendry Irawan

General Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

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Other Identifiers

Profile_DFU

Identifier Type: -

Identifier Source: org_study_id