Clinical trial NCT02736253: Risk Factors for Three Critical Stages of the Diabetic Foot Infections
Official title: Determining of Independent Risk Factors for Three Critical Stages of the Diabetic Foot Infections Without Using the Well-known Classification Systems: Osteomyelitis, Amputation and Major Amputation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Osteomyelitis
Keywords: foot amputation
Osteomyelitis
Diabetic Foot
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were applied to Diabetic Foot Council of Ege University with diabetic foot infections between 2012 and 2014 were included in the study.

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.

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.

Primary outcomes:
measure: Evidence of clinically definite Osteomyelitis
timeFrame: within the first 45 days after admission (hospitalization) (plus or minus 10 days)
measure: The cases applied amputation(minor or major) and The cases applied major amputation
timeFrame: within the first 3 months after admission
Secondary outcomes:
measure: To Decide Independent Risk factors for osteomyelitis in patients with Diabetic Foot Infections
timeFrame: within the first 5±2 days after admission
measure: To Decide Independent Risk factors for AMPUTATION and - for MAJOR AMPUTATION.
timeFrame: within the first 3 months after admission
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University Faculty of Medicine, Diabetic Foot Council
state: Izmir
Study officials:
affiliation: Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey
name: Serhat Uysal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey
name: Bilgin Arda, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey
name: Meltem Işıkgöz Taşbakan, Prof. Dr.
role: STUDY_CHAIR
affiliation: Department of Endocrinology and Metabolism, Ege University, Izmir, Turkey
name: Sevki Cetinkalp, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Department of Endocrinology and Metabolism, Ege University, Izmir, Turkey
name: Ilgin Yildirim Simsir, MD
role: STUDY_CHAIR
affiliation: Department of Orthopedics and Traumatology, Ege University Medical Faculty, Izmir, Turkey
name: Murat Ozturk, MD
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Ege University Medical Faculty, Izmir, Turkey
name: Ayse Uysal, MD
role: STUDY_CHAIR
affiliation: Department of Dermatology, Ege University Medical Faculty, Izmir, Turkey
name: Ilgen Ertam, Prof.Dr.
role: STUDY_CHAIR
References:
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citation: 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.