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Risk Factors for Three Critical Stages of the Diabetic Foot Infections

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ClinicalTrials.gov Identifier: NCT02736253
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Serhat Uysal, Ege University

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.

Condition or disease
Diabetic Foot Osteomyelitis

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.

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Study Type : Observational
Actual Enrollment : 379 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : June 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


  2. 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



Secondary Outcome Measures :
  1. 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.


  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736253


Locations
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Turkey
Ege University Faculty of Medicine, Diabetic Foot Council
Bornova, Izmir, Turkey, 35040
Sponsors and Collaborators
Ege University
Investigators
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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:
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Responsible Party: Serhat Uysal, specialist medical doctor Serhat UYSAL, Ege University
ClinicalTrials.gov Identifier: NCT02736253    
Other Study ID Numbers: 13-1.1/8
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Serhat Uysal, Ege University:
foot amputation
Osteomyelitis
Diabetic Foot
Additional relevant MeSH terms:
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Osteomyelitis
Diabetic Foot
Infection
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases