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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03939000
Enrollment
113
Registered
2019-05-06
Start date
2016-03-31
Completion date
2019-01-31
Last updated
2019-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

clinical profile, diabetic foot ulcer, laboratory finding, tertiary hospital

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.

Interventions

None listed

Sponsors

Udayana University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* DFU patients without surgical intervention.

Design outcomes

Primary

MeasureTime frameDescription
AgeBefore surgeryAge in years
Diabetes mellitus durationBefore surgeryDiabetes mellitus duration in years
Foot ulcer durationBefore surgeryFoot ulcer duration in weeks
GenderBefore surgeryGender is classified to male and female
Foot affectedBefore surgeryFoot affected is classified to right foot, left foot, and bilateral
Wagner classificationBefore surgeryWagner classification is classified to grade 1, grade 2, grade 3, grade 4, and grade 5
Surgical procedureAfter surgerySurgical procedure is classified to debridement, finger amputation, transmetatarsal amputation, below the knee amputation, and above the knee amputation
HemoglobinBefore surgeryHemoglobin in g/dL
HematocritBefore surgeryHematocrit in %
LeukocyteBefore surgeryLeukocyte in 10\^9/L
BasophilBefore surgeryBasophil in 10\^9/L
EosinophilBefore surgeryEosinophil in 10\^9/L
NeutrophilBefore surgeryNeutrophil in 10\^9/L
LymphocyteBefore surgeryLymphocyte in 10\^9/L
MonocyteBefore surgeryMonocyte in 10\^9/L
PlateletBefore surgeryPlatelet in 10\^9/L
Alanine aminotransferaseBefore surgeryAlanine aminotransferase (ALT) in U/L
Aspartate aminotransferaseBefore surgeryAspartate aminotransferase (AST) in U/L
Serum albuminBefore surgerySerum albumin in g/dL
Random blood glucoseBefore surgeryRandom blood glucose in mg/dL
Glycated hemoglobinBefore surgeryGlycated hemoglobin (HbA1c) in %
Blood urea nitrogenBefore surgeryBlood urea nitrogen (BUN) in mg/dL
Serum creatinineBefore surgerySerum creatinine in mg/dL
Serum sodiumBefore surgerySerum sodium in mmol/L
Serum potassiumBefore surgerySerum potassium in mmol/L
Prothrombin timeBefore surgeryProthrombin time (PT) in seconds
Activated partial thromboplastin timeBefore surgeryActivated partial thromboplastin time (APTT) in seconds
International normalized ratioBefore surgeryInternational 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026