4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Clinical Profile and Laboratory Finding of DFU From Tertiary Hospitals in Bali

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

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

Condition or disease
Diabetic Foot Ulcer Type 2 Diabetes Mellitus Laboratory Problem Physical Findings.Skin Ulcer

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 Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Age [ Time Frame: Before surgery ]
    Age in years

  2. Diabetes mellitus duration [ Time Frame: Before surgery ]
    Diabetes mellitus duration in years

  3. Foot ulcer duration [ Time Frame: Before surgery ]
    Foot ulcer duration in weeks

  4. Gender [ Time Frame: Before surgery ]
    Gender is classified to male and female

  5. Foot affected [ Time Frame: Before surgery ]
    Foot affected is classified to right foot, left foot, and bilateral

  6. Wagner classification [ Time Frame: Before surgery ]
    Wagner classification is classified to grade 1, grade 2, grade 3, grade 4, and grade 5

  7. 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

  8. Hemoglobin [ Time Frame: Before surgery ]
    Hemoglobin in g/dL

  9. Hematocrit [ Time Frame: Before surgery ]
    Hematocrit in %

  10. Leukocyte [ Time Frame: Before surgery ]
    Leukocyte in 10^9/L

  11. Basophil [ Time Frame: Before surgery ]
    Basophil in 10^9/L

  12. Eosinophil [ Time Frame: Before surgery ]
    Eosinophil in 10^9/L

  13. Neutrophil [ Time Frame: Before surgery ]
    Neutrophil in 10^9/L

  14. Lymphocyte [ Time Frame: Before surgery ]
    Lymphocyte in 10^9/L

  15. Monocyte [ Time Frame: Before surgery ]
    Monocyte in 10^9/L

  16. Platelet [ Time Frame: Before surgery ]
    Platelet in 10^9/L

  17. Alanine aminotransferase [ Time Frame: Before surgery ]
    Alanine aminotransferase (ALT) in U/L

  18. Aspartate aminotransferase [ Time Frame: Before surgery ]
    Aspartate aminotransferase (AST) in U/L

  19. Serum albumin [ Time Frame: Before surgery ]
    Serum albumin in g/dL

  20. Random blood glucose [ Time Frame: Before surgery ]
    Random blood glucose in mg/dL

  21. Glycated hemoglobin [ Time Frame: Before surgery ]
    Glycated hemoglobin (HbA1c) in %

  22. Blood urea nitrogen [ Time Frame: Before surgery ]
    Blood urea nitrogen (BUN) in mg/dL

  23. Serum creatinine [ Time Frame: Before surgery ]
    Serum creatinine in mg/dL

  24. Serum sodium [ Time Frame: Before surgery ]
    Serum sodium in mmol/L

  25. Serum potassium [ Time Frame: Before surgery ]
    Serum potassium in mmol/L

  26. Prothrombin time [ Time Frame: Before surgery ]
    Prothrombin time (PT) in seconds

  27. Activated partial thromboplastin time [ Time Frame: Before surgery ]
    Activated partial thromboplastin time (APTT) in seconds

  28. 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



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • DFU patients without surgical intervention.
Contacts and Locations

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
 (submitted: May 2, 2019)
  • Age [ Time Frame: Before surgery ]
    Age in years
  • Diabetes mellitus duration [ Time Frame: Before surgery ]
    Diabetes mellitus duration in years
  • Foot ulcer duration [ Time Frame: Before surgery ]
    Foot ulcer duration in weeks
  • Gender [ Time Frame: Before surgery ]
    Gender is classified to male and female
  • Foot affected [ Time Frame: Before surgery ]
    Foot affected is classified to right foot, left foot, and bilateral
  • Wagner classification [ Time Frame: Before surgery ]
    Wagner classification is classified to grade 1, grade 2, grade 3, grade 4, and grade 5
  • 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
  • Hemoglobin [ Time Frame: Before surgery ]
    Hemoglobin in g/dL
  • Hematocrit [ Time Frame: Before surgery ]
    Hematocrit in %
  • Leukocyte [ Time Frame: Before surgery ]
    Leukocyte in 10^9/L
  • Basophil [ Time Frame: Before surgery ]
    Basophil in 10^9/L
  • Eosinophil [ Time Frame: Before surgery ]
    Eosinophil in 10^9/L
  • Neutrophil [ Time Frame: Before surgery ]
    Neutrophil in 10^9/L
  • Lymphocyte [ Time Frame: Before surgery ]
    Lymphocyte in 10^9/L
  • Monocyte [ Time Frame: Before surgery ]
    Monocyte in 10^9/L
  • Platelet [ Time Frame: Before surgery ]
    Platelet in 10^9/L
  • Alanine aminotransferase [ Time Frame: Before surgery ]
    Alanine aminotransferase (ALT) in U/L
  • Aspartate aminotransferase [ Time Frame: Before surgery ]
    Aspartate aminotransferase (AST) in U/L
  • Serum albumin [ Time Frame: Before surgery ]
    Serum albumin in g/dL
  • Random blood glucose [ Time Frame: Before surgery ]
    Random blood glucose in mg/dL
  • Glycated hemoglobin [ Time Frame: Before surgery ]
    Glycated hemoglobin (HbA1c) in %
  • Blood urea nitrogen [ Time Frame: Before surgery ]
    Blood urea nitrogen (BUN) in mg/dL
  • Serum creatinine [ Time Frame: Before surgery ]
    Serum creatinine in mg/dL
  • Serum sodium [ Time Frame: Before surgery ]
    Serum sodium in mmol/L
  • Serum potassium [ Time Frame: Before surgery ]
    Serum potassium in mmol/L
  • Prothrombin time [ Time Frame: Before surgery ]
    Prothrombin time (PT) in seconds
  • Activated partial thromboplastin time [ Time Frame: Before surgery ]
    Activated partial thromboplastin time (APTT) in seconds
  • 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
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
  • Diabetic Foot Ulcer
  • Type 2 Diabetes Mellitus
  • Laboratory Problem
  • Physical Findings.Skin Ulcer
Intervention Not Provided
Study Groups/Cohorts Not Provided
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. Review.
  • 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. Review.
  • 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.
  • International Diabetes Federation. IDF Clinical Practice Recommendations on the Diabetic Foot - 2017: A guide for healthcare professionals. Brussels: International Diabetes Federation; 2017.
  • 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. 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, Dülgeroğlu 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. Review.
  • 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-Wierzgoń M, Kokot T, Swiętochowska 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.

*   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
 (submitted: May 2, 2019)
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:

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

Exclusion Criteria:

  • DFU patients without surgical intervention.
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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