Risk Factors for Three Critical Stages of the Diabetic Foot Infections

April 12, 2016 updated by: Serhat Uysal, Ege University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

379

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Izmir
      • Bornova, Izmir, Turkey, 35040
        • Ege University Faculty of Medicine, Diabetic Foot Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of clinically definite Osteomyelitis
Time Frame: within the first 45 days after admission (hospitalization) (plus or minus 10 days)

Number of cases with osteomyelitis as assessed with using at least two of criteria below:

X-ray graphic imaging, magnetic resonance imaging, bone tissue microbiological culture bone pathological biopsy

Follow-up of patients was completed, after the wound healed. The healing was defined as the complete and uniform skin formation at the wound.
within the first 45 days after admission (hospitalization) (plus or minus 10 days)
The cases applied amputation(minor or major) and The cases applied major amputation
Time Frame: within the first 3 months after admission

Transfemoral, transtibial, knee disarticulation, and hipdisarticulation amputations were decided as MAJOR AMPUTATION.

Other amputation types(more than disarticulation) of lower extremity and major amputations decided as AMPUTATION
within the first 3 months after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Decide Independent Risk factors for osteomyelitis in patients with Diabetic Foot Infections
Time Frame: within the first 5±2 days after admission

Data of the cases were recorded during the admission process with total 58 different situations including the demographic data such as age, gender, type of diabetes and the wound characteristics such as length and width of the wound, the laboratory results such as the number of leukocyte, neutrophil percentage and CRP, monitoring results such as osteomyelitis and arterial occlusion, congestive heart failure, comorbid diseases such as cataracts, tissue culture results, results of microbiological examination, Charcot joints or deformity such as claw-foot.

For determining of data recieved from area of the wound, HD(at least 1900x1080 pixel) images were recorded.

MDR, XDR, PDR enteric gram-negative microorganisms. MRSA, MRCNS, VRE, ESBL-producer determination factor of any microorganism was adopted as the reproduction of "resistant microorganisms"(1)(2). Fungal growth was recorded also in tissue culture.
within the first 5±2 days after admission
To Decide Independent Risk factors for AMPUTATION and - for MAJOR AMPUTATION.
Time Frame: within the first 3 months after admission
Descriptions were similar with ''Independent Risk factors for osteomyelitis'' But: Osteomyelitis was added to the list(s) for both MAJOR AMPUTATION and AMPUTATION For MAJOR AMPUTATION: AMPUTATION was removed from the list. For AMPUTATION : MAJOR AMPUTATION was removed from the list.
within the first 3 months after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Serhat Uysal, MD, Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey
  • Study Director: Bilgin Arda, Prof. Dr., Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey
  • Study Chair: Meltem Işıkgöz Taşbakan, Prof. Dr., Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey
  • Study Director: Sevki Cetinkalp, Prof. Dr., Department of Endocrinology and Metabolism, Ege University, Izmir, Turkey
  • Study Chair: Ilgin Yildirim Simsir, MD, Department of Endocrinology and Metabolism, Ege University, Izmir, Turkey
  • Study Chair: Murat Ozturk, MD, Department of Orthopedics and Traumatology, Ege University Medical Faculty, Izmir, Turkey
  • Study Chair: Ayse Uysal, MD, Department of Internal Medicine, Ege University Medical Faculty, Izmir, Turkey
  • Study Chair: Ilgen Ertam, Prof.Dr., Department of Dermatology, Ege University Medical Faculty, Izmir, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-1.1/8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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