Type 2 Diabetes Mellitus Clinical Trial
Official title:
Clinical Profile and Laboratory Finding of Diabetic Foot Ulcers From Tertiary Hospitals in Bali
NCT number | NCT03939000 |
Other study ID # | Profile_DFU |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | January 2019 |
Verified date | May 2019 |
Source | Udayana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators want to obtain the clinical profile, hematological profile, and biochemical profile from diabetic foot ulcer (DFU) patient.
Status | Completed |
Enrollment | 113 |
Est. completion date | January 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre. Exclusion Criteria: - DFU patients without surgical intervention. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Udayana University |
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Age | Age in years | Before surgery | |
Primary | Diabetes mellitus duration | Diabetes mellitus duration in years | Before surgery | |
Primary | Foot ulcer duration | Foot ulcer duration in weeks | Before surgery | |
Primary | Gender | Gender is classified to male and female | Before surgery | |
Primary | Foot affected | Foot affected is classified to right foot, left foot, and bilateral | Before surgery | |
Primary | Wagner classification | Wagner classification is classified to grade 1, grade 2, grade 3, grade 4, and grade 5 | Before surgery | |
Primary | Surgical procedure | Surgical procedure is classified to debridement, finger amputation, transmetatarsal amputation, below the knee amputation, and above the knee amputation | After surgery | |
Primary | Hemoglobin | Hemoglobin in g/dL | Before surgery | |
Primary | Hematocrit | Hematocrit in % | Before surgery | |
Primary | Leukocyte | Leukocyte in 10^9/L | Before surgery | |
Primary | Basophil | Basophil in 10^9/L | Before surgery | |
Primary | Eosinophil | Eosinophil in 10^9/L | Before surgery | |
Primary | Neutrophil | Neutrophil in 10^9/L | Before surgery | |
Primary | Lymphocyte | Lymphocyte in 10^9/L | Before surgery | |
Primary | Monocyte | Monocyte in 10^9/L | Before surgery | |
Primary | Platelet | Platelet in 10^9/L | Before surgery | |
Primary | Alanine aminotransferase | Alanine aminotransferase (ALT) in U/L | Before surgery | |
Primary | Aspartate aminotransferase | Aspartate aminotransferase (AST) in U/L | Before surgery | |
Primary | Serum albumin | Serum albumin in g/dL | Before surgery | |
Primary | Random blood glucose | Random blood glucose in mg/dL | Before surgery | |
Primary | Glycated hemoglobin | Glycated hemoglobin (HbA1c) in % | Before surgery | |
Primary | Blood urea nitrogen | Blood urea nitrogen (BUN) in mg/dL | Before surgery | |
Primary | Serum creatinine | Serum creatinine in mg/dL | Before surgery | |
Primary | Serum sodium | Serum sodium in mmol/L | Before surgery | |
Primary | Serum potassium | Serum potassium in mmol/L | Before surgery | |
Primary | Prothrombin time | Prothrombin time (PT) in seconds | Before surgery | |
Primary | Activated partial thromboplastin time | Activated partial thromboplastin time (APTT) in seconds | Before surgery | |
Primary | International normalized ratio | 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 |
Before surgery |
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