NCT03939000

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

2.8 years

First QC Date

April 30, 2019

Last Update Submit

May 2, 2019

Conditions

Diabetic Foot UlcerType 2 Diabetes MellitusLaboratory ProblemPhysical Findings.Skin Ulcer

Keywords

clinical profilediabetic foot ulcerlaboratory findingtertiary hospital

Outcome Measures

Primary Outcomes (28)

  • Age

    Age in years

    Before surgery

  • Diabetes mellitus duration

    Diabetes mellitus duration in years

    Before surgery

  • Foot ulcer duration

    Foot ulcer duration in weeks

    Before surgery

  • Gender

    Gender is classified to male and female

    Before surgery

  • Foot affected

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

    Before surgery

  • Wagner classification

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

    Before surgery

  • Surgical procedure

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

    After surgery

  • Hemoglobin

    Hemoglobin in g/dL

    Before surgery

  • Hematocrit

    Hematocrit in %

    Before surgery

  • Leukocyte

    Leukocyte in 10\^9/L

    Before surgery

  • Basophil

    Basophil in 10\^9/L

    Before surgery

  • Eosinophil

    Eosinophil in 10\^9/L

    Before surgery

  • Neutrophil

    Neutrophil in 10\^9/L

    Before surgery

  • Lymphocyte

    Lymphocyte in 10\^9/L

    Before surgery

  • Monocyte

    Monocyte in 10\^9/L

    Before surgery

  • Platelet

    Platelet in 10\^9/L

    Before surgery

  • Alanine aminotransferase

    Alanine aminotransferase (ALT) in U/L

    Before surgery

  • Aspartate aminotransferase

    Aspartate aminotransferase (AST) in U/L

    Before surgery

  • Serum albumin

    Serum albumin in g/dL

    Before surgery

  • Random blood glucose

    Random blood glucose in mg/dL

    Before surgery

  • Glycated hemoglobin

    Glycated hemoglobin (HbA1c) in %

    Before surgery

  • Blood urea nitrogen

    Blood urea nitrogen (BUN) in mg/dL

    Before surgery

  • Serum creatinine

    Serum creatinine in mg/dL

    Before surgery

  • Serum sodium

    Serum sodium in mmol/L

    Before surgery

  • Serum potassium

    Serum potassium in mmol/L

    Before surgery

  • Prothrombin time

    Prothrombin time (PT) in seconds

    Before surgery

  • Activated partial thromboplastin time

    Activated partial thromboplastin time (APTT) in seconds

    Before surgery

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • DFU patients without surgical intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (26)

  • 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.

    PMID: 29219149BACKGROUND

  • 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.

    PMID: 27222545BACKGROUND

  • 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.

    PMID: 24353273BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 15470219BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16515230BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 26651032BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 30176260BACKGROUND

  • 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.

    PMID: 28682678BACKGROUND

  • 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.

    PMID: 25667237BACKGROUND

  • 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.

    PMID: 30336205BACKGROUND

  • 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.

    PMID: 22181049BACKGROUND

  • 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.

    PMID: 29950877BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 27887858BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 30158840BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 23843866BACKGROUND

MeSH Terms

Conditions

Diabetic FootDiabetes Mellitus, Type 2Skin Ulcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 6, 2019

Study Start

March 1, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

May 6, 2019

Record last verified: 2019-05