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Diabetic Foot UlcerNCT03939000

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

An observational study of Diabetic Foot Ulcer and Type 2 Diabetes Mellitus, run by Udayana University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Any age
How many people
113 participants
Where
No sites listed yet
Study dates
Mar 2016to Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All DFU patients who underwent surgical procedures in Sanglah General Hospital operating theatre.

Who may be able to join

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

Who cannot join

  • DFU patients without surgical intervention.

About this study

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

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

Read the 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.

Keywords
clinical profile, diabetic foot ulcer, laboratory finding, tertiary hospital
Medical subject headings
Diabetic Foot, Diabetes Mellitus, Type 2, Skin Ulcer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age

    Age in years

    Measured: Before surgery

  2. Diabetes mellitus duration

    Diabetes mellitus duration in years

    Measured: Before surgery

  3. Foot ulcer duration

    Foot ulcer duration in weeks

    Measured: Before surgery

  4. Gender

    Gender is classified to male and female

    Measured: Before surgery

  5. Foot affected

    Foot affected is classified to right foot, left foot, and bilateral

    Measured: Before surgery

  6. Wagner classification

    Wagner classification is classified to grade 1, grade 2, grade 3, grade 4, and grade 5

    Measured: Before surgery

  7. Surgical procedure

    Surgical procedure is classified to debridement, finger amputation, transmetatarsal amputation, below the knee amputation, and above the knee amputation

    Measured: After surgery

  8. Hemoglobin

    Hemoglobin in g/dL

    Measured: Before surgery

  9. Hematocrit

    Hematocrit in %

    Measured: Before surgery

  10. Leukocyte

    Leukocyte in 10^9/L

    Measured: Before surgery

  11. Basophil

    Basophil in 10^9/L

    Measured: Before surgery

  12. Eosinophil

    Eosinophil in 10^9/L

    Measured: Before surgery

  13. Neutrophil

    Neutrophil in 10^9/L

    Measured: Before surgery

  14. Lymphocyte

    Lymphocyte in 10^9/L

    Measured: Before surgery

  15. Monocyte

    Monocyte in 10^9/L

    Measured: Before surgery

  16. Platelet

    Platelet in 10^9/L

    Measured: Before surgery

  17. Alanine aminotransferase

    Alanine aminotransferase (ALT) in U/L

    Measured: Before surgery

  18. Aspartate aminotransferase

    Aspartate aminotransferase (AST) in U/L

    Measured: Before surgery

  19. Serum albumin

    Serum albumin in g/dL

    Measured: Before surgery

  20. Random blood glucose

    Random blood glucose in mg/dL

    Measured: Before surgery

  21. Glycated hemoglobin

    Glycated hemoglobin (HbA1c) in %

    Measured: Before surgery

  22. Blood urea nitrogen

    Blood urea nitrogen (BUN) in mg/dL

    Measured: Before surgery

  23. Serum creatinine

    Serum creatinine in mg/dL

    Measured: Before surgery

  24. Serum sodium

    Serum sodium in mmol/L

    Measured: Before surgery

  25. Serum potassium

    Serum potassium in mmol/L

    Measured: Before surgery

  26. Prothrombin time

    Prothrombin time (PT) in seconds

    Measured: Before surgery

  27. Activated partial thromboplastin time

    Activated partial thromboplastin time (APTT) in seconds

    Measured: Before surgery

  28. 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

    Measured: Before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study startMar 2016
  3. Primary completionDec 2018
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03939000
Sponsor's protocol ID
Profile_DFU
Status last verified
May 2019
First submitted
30 Apr 2019
Last updated
6 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 29219149

  • 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.

    PubMed 27222545

  • 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.

    PubMed 24353273

  • 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. doi: 10.1056/NEJMcpc049016. No abstract available.

    PubMed 15470219

  • 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.

    PubMed 16515230

  • 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.

    PubMed 26651032

  • 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.

    PubMed 30176260

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Foot Ulcer and Type 2 Diabetes Mellitus, run by Udayana University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age (time frame: Before surgery). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03939000, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.

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