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Completed

NCT Number: NCT02736253

Risk Factors for Three Critical Stages of the Diabetic Foot Infections

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.

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Key information

Conditions

Diabetic Foot Bone Diseases Bone Diseases, Infectious Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Infections Leg Ulcer Musculoskeletal Diseases Osteomyelitis Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ege University Faculty of Medicine, Diabetic Foot Council

Bornova, İzmir, 35040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 13, 2016
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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