Clinical Trials Directory

Trials / Completed

CompletedNCT02736253

Risk Factors for Three Critical Stages of the Diabetic Foot Infections

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

Status
Completed
Phase
Study type
Observational
Enrollment
379 (actual)
Sponsor
Ege University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2012-06-01
Primary completion
2014-06-01
Completion
2015-02-01
First posted
2016-04-13
Last updated
2016-04-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT02736253. Inclusion in this directory is not an endorsement.