- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03939000
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
Study Overview
Status
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre.
Exclusion Criteria:
- DFU patients without surgical intervention.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: Before surgery
|
Age in years
|
Before surgery
|
Diabetes mellitus duration
Time Frame: Before surgery
|
Diabetes mellitus duration in years
|
Before surgery
|
Foot ulcer duration
Time Frame: Before surgery
|
Foot ulcer duration in weeks
|
Before surgery
|
Gender
Time Frame: Before surgery
|
Gender is classified to male and female
|
Before surgery
|
Foot affected
Time Frame: Before surgery
|
Foot affected is classified to right foot, left foot, and bilateral
|
Before surgery
|
Wagner classification
Time Frame: Before surgery
|
Wagner classification is classified to grade 1, grade 2, grade 3, grade 4, and grade 5
|
Before surgery
|
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
|
After surgery
|
Hemoglobin
Time Frame: Before surgery
|
Hemoglobin in g/dL
|
Before surgery
|
Hematocrit
Time Frame: Before surgery
|
Hematocrit in %
|
Before surgery
|
Leukocyte
Time Frame: Before surgery
|
Leukocyte in 10^9/L
|
Before surgery
|
Basophil
Time Frame: Before surgery
|
Basophil in 10^9/L
|
Before surgery
|
Eosinophil
Time Frame: Before surgery
|
Eosinophil in 10^9/L
|
Before surgery
|
Neutrophil
Time Frame: Before surgery
|
Neutrophil in 10^9/L
|
Before surgery
|
Lymphocyte
Time Frame: Before surgery
|
Lymphocyte in 10^9/L
|
Before surgery
|
Monocyte
Time Frame: Before surgery
|
Monocyte in 10^9/L
|
Before surgery
|
Platelet
Time Frame: Before surgery
|
Platelet in 10^9/L
|
Before surgery
|
Alanine aminotransferase
Time Frame: Before surgery
|
Alanine aminotransferase (ALT) in U/L
|
Before surgery
|
Aspartate aminotransferase
Time Frame: Before surgery
|
Aspartate aminotransferase (AST) in U/L
|
Before surgery
|
Serum albumin
Time Frame: Before surgery
|
Serum albumin in g/dL
|
Before surgery
|
Random blood glucose
Time Frame: Before surgery
|
Random blood glucose in mg/dL
|
Before surgery
|
Glycated hemoglobin
Time Frame: Before surgery
|
Glycated hemoglobin (HbA1c) in %
|
Before surgery
|
Blood urea nitrogen
Time Frame: Before surgery
|
Blood urea nitrogen (BUN) in mg/dL
|
Before surgery
|
Serum creatinine
Time Frame: Before surgery
|
Serum creatinine in mg/dL
|
Before surgery
|
Serum sodium
Time Frame: Before surgery
|
Serum sodium in mmol/L
|
Before surgery
|
Serum potassium
Time Frame: Before surgery
|
Serum potassium in mmol/L
|
Before surgery
|
Prothrombin time
Time Frame: Before surgery
|
Prothrombin time (PT) in seconds
|
Before surgery
|
Activated partial thromboplastin time
Time Frame: Before surgery
|
Activated partial thromboplastin time (APTT) in seconds
|
Before surgery
|
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 |
Before surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.
- Zimmet PZ, Alberti KG. Epidemiology of Diabetes-Status of a Pandemic and Issues Around Metabolic Surgery. Diabetes Care. 2016 Jun;39(6):878-83. doi: 10.2337/dc16-0273.
- Balducci S, Sacchetti M, Haxhi J, Orlando G, D'Errico V, Fallucca S, Menini S, Pugliese G. Physical exercise as therapy for type 2 diabetes mellitus. Diabetes Metab Res Rev. 2014 Mar;30 Suppl 1:13-23. doi: 10.1002/dmrr.2514.
- Kayssi A, Rogers LC, Neville RF. General Considerations in Diabetic Foot Ulcers. In: Sidawy AN and Perler BA, editors. Rutherford's Vascular Surgery and Endovascular Therapy. 9th ed. Philadelphia: Elsevier Inc; 2019. p.1514-26.
- Ibrahim A. IDF Clinical Practice Recommendation on the Diabetic Foot: A guide for healthcare professionals. Diabetes Res Clin Pract. 2017 May;127:285-287. doi: 10.1016/j.diabres.2017.04.013. Epub 2017 Apr 9. No abstract available.
- Pemayun TGD, Naibaho RM. Diabetes Management Diabetic Foot Ulcer Registry at a Tertiary Care Hospital in Semarang, Indonesia: an Overview of its Clinical Profile and Management Outcome. J Clin Diabetes Pract. 2016;1:111.
- Leong M, Murphy KD, Phillips LG. Wound Healing. In: Townsend Jr CM, Beauchamp RD, Evers BM, Mattox KL, editors. Sabiston Textbook of Surgery: The Biological Basis of Modern Surgical Practice. 20th ed. Philadelphia: Elsevier Inc; 2017. p.130-62.
- Barbul A, Efron DT, Kavalukas SL. Wound Healing. In: Brunicardi FC, Andersen DK, Billiar TR, et al, editors. Schwartz Principles of Surgery. 10th ed. New York: McGraw Hill Education; 2015. p. 241-71.
- Kratz A, Ferraro M, Sluss PM, Lewandrowski KB. Case records of the Massachusetts General Hospital. Weekly clinicopathological exercises. Laboratory reference values. N Engl J Med. 2004 Oct 7;351(15):1548-63. doi: 10.1056/NEJMcpc049016. No abstract available. Erratum In: N Engl J Med. 2004 Oct 7;351(23):2461.
- Powers AC. Diabetes Mellitus. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson JL, Loscalzo J, editors. Harrison's Principles of Internal Medicine. 18th ed. New York: McGraw Hill Education; 2011. p.2968-2970.
- Viswanathan V, Thomas N, Tandon N, Asirvatham A, Rajasekar S, Ramachandran A, Senthilvasan K, Murugan VS, Muthulakshmi. Profile of diabetic foot complications and its associated complications--a multicentric study from India. J Assoc Physicians India. 2005 Nov;53:933-6.
- Tarigan TJE, Yunir E, Subekti I, Pramono LA, Martina D. Profile and analysis of diabetes chronic complications in Outpatient Diabetes Clinic of Cipto Mangunkusumo Hospital, Jakarta. Med J Indones. 2015;24:156-62.
- Pemayun TG, Naibaho RM, Novitasari D, Amin N, Minuljo TT. Risk factors for lower extremity amputation in patients with diabetic foot ulcers: a hospital-based case-control study. Diabet Foot Ankle. 2015 Dec 7;6:29629. doi: 10.3402/dfa.v6.29629. eCollection 2015.
- Bowker JH. Minor and Major Lower-Limb Amputations and Disarticulations in Patients with Diabetes Mellitus. In: Bowker JH, Pfeifer MA. Levin and O'Neal's the Diabetic Foot. 7th ed. Philadelphia: Elsevier Inc; 2008. p.403-28.
- Demirdal T, Sen P. The significance of neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte ratio in predicting peripheral arterial disease, peripheral neuropathy, osteomyelitis and amputation in diabetic foot infection. Diabetes Res Clin Pract. 2018 Oct;144:118-125. doi: 10.1016/j.diabres.2018.08.009. Epub 2018 Sep 1.
- Metineren H, Dulgeroglu TC. Comparison of the Neutrophil/Lymphocyte Ratio and C-Reactive Protein Levels in Patients With Amputation for Diabetic Foot Ulcers. Int J Low Extrem Wounds. 2017 Mar;16(1):23-28. doi: 10.1177/1534734617696729. Epub 2017 Mar 8.
- Balta S, Celik T, Mikhailidis DP, Ozturk C, Demirkol S, Aparci M, Iyisoy A. The Relation Between Atherosclerosis and the Neutrophil-Lymphocyte Ratio. Clin Appl Thromb Hemost. 2016 Jul;22(5):405-11. doi: 10.1177/1076029615569568. Epub 2015 Feb 9.
- Goldman MP, Clark CJ, Craven TE, Davis RP, Williams TK, Velazquez-Ramirez G, Hurie JB, Edwards MS. Effect of Intensive Glycemic Control on Risk of Lower Extremity Amputation. J Am Coll Surg. 2018 Dec;227(6):596-604. doi: 10.1016/j.jamcollsurg.2018.09.021. Epub 2018 Oct 16.
- Bhonsle HS, Korwar AM, Kote SS, Golegaonkar SB, Chougale AD, Shaik ML, Dhande NL, Giri AP, Shelgikar KM, Boppana R, Kulkarni MJ. Low plasma albumin levels are associated with increased plasma protein glycation and HbA1c in diabetes. J Proteome Res. 2012 Feb 3;11(2):1391-6. doi: 10.1021/pr201030m. Epub 2012 Jan 6.
- Shatnawi NJ, Al-Zoubi NA, Hawamdeh HM, Khader YS, Garaibeh K, Heis HA. Predictors of major lower limb amputation in type 2 diabetic patients referred for hospital care with diabetic foot syndrome. Diabetes Metab Syndr Obes. 2018 Jun 22;11:313-319. doi: 10.2147/DMSO.S165967. eCollection 2018.
- Kahraman C, Yümün G, Kahraman NK, Namdar ND, Cosgun S. Neutrophil-to-lymphocyte ratio in diabetes mellitus patients with and without diabetic foot ulcer. Eur J Med Sci. 2014;1:8-13.
- Vatankhah N, Jahangiri Y, Landry GJ, McLafferty RB, Alkayed NJ, Moneta GL, Azarbal AF. Predictive value of neutrophil-to-lymphocyte ratio in diabetic wound healing. J Vasc Surg. 2017 Feb;65(2):478-483. doi: 10.1016/j.jvs.2016.08.108. Epub 2016 Nov 23.
- Semadi IN, Irawan H. Blood glucose and lipid profile in patients with diabetic foot ulcer that underwent hyperbaric oxygen therapy. Bali Med J. 2017;6:405-8.
- Irawan H, Semadi IN, Widiana IGR. A Pilot Study of Short-Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine in Patients with Diabetic Foot Ulcer Wagner 3-4. ScientificWorldJournal. 2018 Aug 12;2018:6425857. doi: 10.1155/2018/6425857. eCollection 2018.
- Wounds International. International Best Practice Guidelines: Wound Management in Diabetic Foot Ulcers. London: Wounds International A division of Schofield Healthcare Media Limited Enterprise House; 2013.
- Waniczek D, Kozowicz A, Muc-Wierzgon M, Kokot T, Swietochowska E, Nowakowska-Zajdel E. Adjunct methods of the standard diabetic foot ulceration therapy. Evid Based Complement Alternat Med. 2013;2013:243568. doi: 10.1155/2013/243568. Epub 2013 Jun 13.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Diabetes Mellitus, Type 2
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Skin Ulcer
Other Study ID Numbers
- Profile_DFU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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