Risk Factors for Three Critical Stages of the Diabetic Foot Infections

Completed

• Conditions: Diabetic Foot; Osteomyelitis

• Registration Number: NCT02736253
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-06
• Primary Completion: 2014-06
• Study Completion: 2015-02
• Status Verified: 2016-04
• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-12
• Last Update Submitted: 2016-04-12
• Study First Posted: 2016-04-13
• Last Update Posted: 2016-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Ege University Faculty of Medicine, Diabetic Foot Council; 🇹🇷 Bornova, Izmir, Turkey