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NCT Number: NCT03939000

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

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

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Laboratory Problem Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Physical Findings.Skin Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Type 2 Diabetes Mellitus Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • DFU patients without surgical intervention.

Treatment and study plan

Primary outcomes

  1. Age

    Time frame: Before surgery

    Age in years

  2. Diabetes mellitus duration

    Time frame: Before surgery

    Diabetes mellitus duration in years

  3. Foot ulcer duration

    Time frame: Before surgery

    Foot ulcer duration in weeks

  4. Gender

    Time frame: Before surgery

    Gender is classified to male and female

  5. Foot affected

    Time frame: Before surgery

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

  6. Wagner classification

    Time frame: Before surgery

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

  7. 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

  8. Hemoglobin

    Time frame: Before surgery

    Hemoglobin in g/dL

  9. Hematocrit

    Time frame: Before surgery

    Hematocrit in %

  10. Leukocyte

    Time frame: Before surgery

    Leukocyte in 10^9/L

  11. Basophil

    Time frame: Before surgery

    Basophil in 10^9/L

  12. Eosinophil

    Time frame: Before surgery

    Eosinophil in 10^9/L

  13. Neutrophil

    Time frame: Before surgery

    Neutrophil in 10^9/L

  14. Lymphocyte

    Time frame: Before surgery

    Lymphocyte in 10^9/L

  15. Monocyte

    Time frame: Before surgery

    Monocyte in 10^9/L

  16. Platelet

    Time frame: Before surgery

    Platelet in 10^9/L

  17. Alanine aminotransferase

    Time frame: Before surgery

    Alanine aminotransferase (ALT) in U/L

  18. Aspartate aminotransferase

    Time frame: Before surgery

    Aspartate aminotransferase (AST) in U/L

  19. Serum albumin

    Time frame: Before surgery

    Serum albumin in g/dL

  20. Random blood glucose

    Time frame: Before surgery

    Random blood glucose in mg/dL

  21. Glycated hemoglobin

    Time frame: Before surgery

    Glycated hemoglobin (HbA1c) in %

  22. Blood urea nitrogen

    Time frame: Before surgery

    Blood urea nitrogen (BUN) in mg/dL

  23. Serum creatinine

    Time frame: Before surgery

    Serum creatinine in mg/dL

  24. Serum sodium

    Time frame: Before surgery

    Serum sodium in mmol/L

  25. Serum potassium

    Time frame: Before surgery

    Serum potassium in mmol/L

  26. Prothrombin time

    Time frame: Before surgery

    Prothrombin time (PT) in seconds

  27. Activated partial thromboplastin time

    Time frame: Before surgery

    Activated partial thromboplastin time (APTT) in seconds

  28. 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

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 6, 2019
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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