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
|Condition or disease|
|Diabetic Foot Osteomyelitis|
|Study Type :||Observational|
|Actual Enrollment :||379 participants|
|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|
- 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.
- 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
- 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.
- 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.
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
|Ege University Faculty of Medicine, Diabetic Foot Council|
|Bornova, Izmir, Turkey, 35040|
|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|