Risk Factors for Three Critical Stages of the Diabetic Foot Infections

NCT ID: NCT02736253

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 379 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-02-28

Brief Summary

In this study, it was aimed to evaluate the independent risk factors for osteomyelitis, amputation and major amputation of the diabetic foot infection in the forward direction without using standard scoring procedures.

Detailed Description

In this study, it was aimed to evaluate the independent risk factors for osteomyelitis, amputation and major amputation of the diabetic foot infection in the forward direction without using standard scoring procedures. Patients who were applied to Diabetic Foot Council of our setting with diabetic foot infections between 2012 and 2014 were included in the study. Patients were followed prospectively and ethical approval was obtained from research ethics committee of our setting. An informed consent form was provided by each patient. Diabetic foot infection was decided as local infection involving only the skin and the subcutaneous tissue or infection involving symptoms and signs more than this criterion. Properties and variables of the cases were recorded during the admission process with total 57 different situations. The related characteristics were followed until the end of the treatment. Osteomyelitis, amputation and factors affecting to have major amputation on the cases were investigated. In the first step, data normality tests were performed with a simple data analysis and univariate analysis was applied in the second stage to which meaningful. At the last stage, major amputation, amputation and osteomyelitis were analyzed with stepwise multiple logistic analysis (SLA) model. Logistic regression was subject as significant data were saved as the independent risk factor. The Odds ratio and 95% CI were calculated from the beta coefficients of the variables with significant p value. P < 0.05 was used for significance at all tests.

Conditions

Diabetic Foot; Osteomyelitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Volunteer to participate in research (An informed consent form was provided by each patient),
• Patient with infected diabetic foot,
• The lack of mental retardation or mental disorders

Exclusion Criteria

• The patient refused to participate in the study,
• Age < 18 years.
• Patient's opinion or participation in another clinical trial
• The patient has previously been recruited to the study.
• Another rapidly progressive or terminal illness.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Serhat Uysal

specialist medical doctor Serhat UYSAL

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serhat Uysal, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey

Bilgin Arda, Prof. Dr.

Role: STUDY_DIRECTOR

Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey

Meltem Işıkgöz Taşbakan, Prof. Dr.

Role: STUDY_CHAIR

Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey

Sevki Cetinkalp, Prof. Dr.

Role: STUDY_DIRECTOR

Department of Endocrinology and Metabolism, Ege University, Izmir, Turkey

Ilgin Yildirim Simsir, MD

Role: STUDY_CHAIR

Department of Endocrinology and Metabolism, Ege University, Izmir, Turkey

Murat Ozturk, MD

Role: STUDY_CHAIR

Department of Orthopedics and Traumatology, Ege University Medical Faculty, Izmir, Turkey

Ayse Uysal, MD

Role: STUDY_CHAIR

Department of Internal Medicine, Ege University Medical Faculty, Izmir, Turkey

Ilgen Ertam, Prof.Dr.

Role: STUDY_CHAIR

Department of Dermatology, Ege University Medical Faculty, Izmir, Turkey

Locations

Ege University Faculty of Medicine, Diabetic Foot Council

Bornova, İzmir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.1111/j.1469-0691.2011.03570.x. Epub 2011 Jul 27.

Reference Type: BACKGROUND

PMID: 21793988 (View on PubMed)

Baio PV, Mota HF, Freitas AD, Gomes DL, Ramos JN, Sant'Anna LO, Souza MC, Camello TC, Hirata Junior R, Vieira VV, Mattos-Guaraldi AL. Clonal multidrug-resistant Corynebacterium striatum within a nosocomial environment, Rio de Janeiro, Brazil. Mem Inst Oswaldo Cruz. 2013 Feb;108(1):23-9. doi: 10.1590/s0074-02762013000100004.

Reference Type: BACKGROUND

PMID: 23440110 (View on PubMed)

Other Identifiers

13-1.1/8

Identifier Type: -

Identifier Source: org_study_id