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 |
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
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | April 30, 2019 | ||||
First Posted Date | May 6, 2019 | ||||
Last Update Posted Date | May 6, 2019 | ||||
Actual Study Start Date | March 2016 | ||||
Actual Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | 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 | ||||
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. |
||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | All DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre. | ||||
Condition |
|
||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * |
|
||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
113 | ||||
Original Actual Enrollment | Same as current | ||||
Actual Study Completion Date | January 2019 | ||||
Actual Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03939000 | ||||
Other Study ID Numbers | Profile_DFU | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | Hendry Irawan, Udayana University | ||||
Study Sponsor | Udayana University | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Udayana University | ||||
Verification Date | May 2019 |