Diabetic FootNCT02736253
Risk Factors for Three Critical Stages of the Diabetic Foot Infections
An observational study of Diabetic Foot and Osteomyelitis, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Osteomyelitis
- How many people
- 379 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were applied to Diabetic Foot Council of Ege University with diabetic foot infections between 2012 and 2014 were included in the study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine, Diabetic Foot Council
Bornova, İzmir, 35040
About this study
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
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.
Read the 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
- Diabetic Foot, Osteomyelitis
- Keywords
- foot amputation, Osteomyelitis, Diabetic Foot
- Medical subject headings
- Diabetic Foot, Osteomyelitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 45 days after admission (hospitalization) (plus or minus 10 days)
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
Measured: within the first 3 months after admission
Secondary outcomes (2)
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.
Measured: within the first 5±2 days after admission
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.
Measured: within the first 3 months after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serhat Uysal, Ege University
- Investigators
- Serhat Uysal, MD, Principal investigator, Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, TurkeyBilgin Arda, Prof. Dr., Study director, Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, TurkeyMeltem Işıkgöz Taşbakan, Prof. Dr., Study chair, Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, TurkeySevki Cetinkalp, Prof. Dr., Study director, Department of Endocrinology and Metabolism, Ege University, Izmir, TurkeyIlgin Yildirim Simsir, MD, Study chair, Department of Endocrinology and Metabolism, Ege University, Izmir, TurkeyMurat Ozturk, MD, Study chair, Department of Orthopedics and Traumatology, Ege University Medical Faculty, Izmir, TurkeyAyse Uysal, MD, Study chair, Department of Internal Medicine, Ege University Medical Faculty, Izmir, TurkeyIlgen Ertam, Prof.Dr., Study chair, Department of Dermatology, Ege University Medical Faculty, Izmir, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736253
- Sponsor's protocol ID
- 13-1.1/8
- Status last verified
- Apr 2016
- First submitted
- 1 Apr 2016
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 21793988Baio 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. doi: 10.1590/s0074-02762013000100004.
PubMed 23440110
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02736253
- Acronym / sponsor ID
- 13-1.1/8
- Conditions
- Diabetic Foot, Osteomyelitis
- Keywords
- foot amputation, Osteomyelitis, Diabetic Foot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were applied to Diabetic Foot Council of Ege University with diabetic foot infections between 2012 and 2014 were included in the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
To Decide Independent Risk factors for osteomyelitis in patients with Diabetic Foot Infections
Time frame: within the first 5±2 days after admission
To Decide Independent Risk factors for AMPUTATION and - for MAJOR AMPUTATION.
Time frame: within the first 3 months after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Background: PubMed 21793988Magiorakos 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.
- Background: PubMed 23440110Baio 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. doi: 10.1590/s0074-02762013000100004.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serhat Uysal, MD principal investigator
Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey
Bilgin Arda, Prof. Dr. study director
Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey
Meltem Işıkgöz Taşbakan, Prof. Dr. study chair
Department of Infectious Diseases and Clinical Microbiology, Ege University, Izmir, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Osteomyelitis, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically definite Osteomyelitis (time frame: within the first 45 days after admission (hospitalization) (plus or minus 10 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02736253, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.