Risk Factors for Three Critical Stages of the Diabetic Foot Infections

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT02736253

Collaborator

(none)

379

Enrollment

Location

Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

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 :

Jun 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Feb 1, 2015

Outcome Measures

Primary Outcome Measures

Evidence of clinically definite Osteomyelitis [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.
The cases applied amputation(minor or major) and The cases applied major amputation [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

To Decide Independent Risk factors for osteomyelitis in patients with Diabetic Foot Infections [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.
To Decide Independent Risk factors for AMPUTATION and - for MAJOR AMPUTATION. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University Faculty of Medicine, Diabetic Foot Council	Bornova	Izmir	Turkey	35040

Sponsors and Collaborators

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