Clinical Profile and Laboratory Finding of DFU From Tertiary Hospitals in Bali
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03939000 |
|
Recruitment Status :
Completed
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Diabetic Foot Ulcer Type 2 Diabetes Mellitus Laboratory Problem Physical Findings.Skin Ulcer |
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 Type : | Observational |
| Actual Enrollment : | 113 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Clinical Profile and Laboratory Finding of Diabetic Foot Ulcers From Tertiary Hospitals in Bali |
| Actual Study Start Date : | March 2016 |
| Actual Primary Completion Date : | December 2018 |
| Actual Study Completion Date : | January 2019 |
- Age [ Time Frame: Before surgery ]Age in years
- Diabetes mellitus duration [ Time Frame: Before surgery ]Diabetes mellitus duration in years
- Foot ulcer duration [ Time Frame: Before surgery ]Foot ulcer duration in weeks
- Gender [ Time Frame: Before surgery ]Gender is classified to male and female
- Foot affected [ Time Frame: Before surgery ]Foot affected is classified to right foot, left foot, and bilateral
- Wagner classification [ Time Frame: Before surgery ]Wagner classification is classified to grade 1, grade 2, grade 3, grade 4, and grade 5
- 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 %
- Leukocyte [ Time Frame: Before surgery ]Leukocyte in 10^9/L
- Basophil [ Time Frame: Before surgery ]Basophil in 10^9/L
- Eosinophil [ Time Frame: Before surgery ]Eosinophil in 10^9/L
- Neutrophil [ Time Frame: Before surgery ]Neutrophil in 10^9/L
- Lymphocyte [ Time Frame: Before surgery ]Lymphocyte in 10^9/L
- Monocyte [ Time Frame: Before surgery ]Monocyte in 10^9/L
- Platelet [ Time Frame: Before surgery ]Platelet in 10^9/L
- Alanine aminotransferase [ Time Frame: Before surgery ]Alanine aminotransferase (ALT) in U/L
- Aspartate aminotransferase [ Time Frame: Before surgery ]Aspartate aminotransferase (AST) in U/L
- Serum albumin [ Time Frame: Before surgery ]Serum albumin in g/dL
- Random blood glucose [ Time Frame: Before surgery ]Random blood glucose in mg/dL
- Glycated hemoglobin [ Time Frame: Before surgery ]Glycated hemoglobin (HbA1c) in %
- Blood urea nitrogen [ Time Frame: Before surgery ]Blood urea nitrogen (BUN) in mg/dL
- Serum creatinine [ Time Frame: Before surgery ]Serum creatinine in mg/dL
- Serum sodium [ Time Frame: Before surgery ]Serum sodium in mmol/L
- Serum potassium [ Time Frame: Before surgery ]Serum potassium in mmol/L
- Prothrombin time [ Time Frame: Before surgery ]Prothrombin time (PT) in seconds
- Activated partial thromboplastin time [ Time Frame: Before surgery ]Activated partial thromboplastin time (APTT) in seconds
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre.
Exclusion Criteria:
- DFU patients without surgical intervention.
| Responsible Party: | Hendry Irawan, General Surgeon, Udayana University |
| ClinicalTrials.gov Identifier: | NCT03939000 |
| Other Study ID Numbers: |
Profile_DFU |
| First Posted: | May 6, 2019 Key Record Dates |
| Last Update Posted: | May 6, 2019 |
| Last Verified: | May 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
clinical profile diabetic foot ulcer laboratory finding tertiary hospital |
|
Diabetic Foot Foot Ulcer Skin Ulcer Diabetes Mellitus, Type 2 Ulcer Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Diseases Diabetes Complications Diabetic Neuropathies Foot Diseases |