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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939000
• Other study ID #: Profile_DFU
• Status: Completed
• Start date: March 2016
• Est. completion date: January 2019

Study information

• Verified date: May 2019
• Source: Udayana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators want to obtain the clinical profile, hematological profile, and biochemical profile from diabetic foot ulcer (DFU) patient.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Laboratory Problem
• Physical Findings.Skin Ulcer
• Signs and Symptoms
• Skin Ulcer
• Type 2 Diabetes Mellitus
• Ulcer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Udayana University

References & Publications (26)

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. Review. — View Citation

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. Review. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

International Diabetes Federation. IDF Clinical Practice Recommendations on the Diabetic Foot - 2017: A guide for healthcare professionals. Brussels: International Diabetes Federation; 2017.

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. — View Citation

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.

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.

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. Erratum in: N Engl J Med. 2004 Oct 7;351(23):2461. — View Citation

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.

Metineren H, Dülgeroglu 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. — View Citation

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. — View Citation

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.

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.

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.

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. Review. — View Citation

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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

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