Risk Factors for Three Critical Stages of the Diabetic Foot Infections

Diabetic Foot Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736253
• Other study ID #: 13-1.1/8
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: April 12, 2016
• Start date: June 2012
• Est. completion date: February 2015

Study information

• Verified date: April 2016
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: February 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Foot
• Osteomyelitis

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine, Diabetic Foot Council	Bornova	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	Ege University Faculty of Medicine

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Baio PV, Mota HF, Freitas AD, Gomes DL, Ramos JN, Sant'Anna LO, Souza MC, Camello TC, Hirata Junior R, Vieira VV, Mattos-Guaraldi AL. Clonal multidrug-resistant Corynebacterium striatum within a nosocomial environment, Rio de Janeiro, Brazil. Mem Inst Oswaldo Cruz. 2013 Feb;108(1):23-9. — View Citation

Magiorakos AP, Srinivasan A, Carey RB, Carmeli Y, Falagas ME, Giske CG, Harbarth S, Hindler JF, Kahlmeter G, Olsson-Liljequist B, Paterson DL, Rice LB, Stelling J, Struelens MJ, Vatopoulos A, Weber JT, Monnet DL. Multidrug-resistant, extensively drug-resistant and pandrug-resistant bacteria: an international expert proposal for interim standard definitions for acquired resistance. Clin Microbiol Infect. 2012 Mar;18(3):268-81. doi: 10.1111/j.1469-0691.2011.03570.x. Epub 2011 Jul 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically definite Osteomyelitis	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.	within the first 45 days after admission (hospitalization) (plus or minus 10 days)	Yes
Primary	The cases applied amputation(minor or major) and The cases applied major amputation	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	within the first 3 months after admission	Yes
Secondary	To Decide Independent Risk factors for osteomyelitis in patients with Diabetic Foot Infections	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.	within the first 5±2 days after admission	Yes
Secondary	To Decide Independent Risk factors for AMPUTATION and - for MAJOR AMPUTATION.	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.	within the first 3 months after admission	Yes