InfectionTURK-DAYNCT02026830
The Microbiologic Profile of Diabetic Foot Infections in Turkey - TURK-DAY
An observational study of Infection, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
To determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- How many people
- 447 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jul 2014
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with DM presenting with a diabetic foot infection will be enrolled in the current trial to determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.
Who may be able to join
- Established diagnosis of Diabetes Mellitus
- Diabetic foot wound clinically diagnosed as infected
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
GATA Haydarpasa Egitim Hastanesi
Istanbul, No State Required, 34068
About this study
Official title: The Microbiologic Profile of Diabetic Foot Infections in Turkey (TURK-DAY): Prospective Multicenter Cohort Study
To determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.
Read the detailed description
Recent studies have demonstrated substantial variation in the etiology of DFIs (Diabetic Foot Infections) in different regions of the world . In contrast to Western countries, studies from Asia and Africa have demonstrated that aerobic gram-negative organisms, particularly Pseudomonas aeruginosa, are far more common . The majority of current guidelines for the management of DFIs have been prepared in Western countries . Based on the results of more recent studies from the Asian continent, however, empiric antibiotic therapy for DFIs may need to be directed at organisms with substantially different antibiotic susceptibility patterns than those recommended in current guidelines. Thus, suggested antibiotic regimens for DFIs should be optimized for local clinical practice. The aim of the current trial is to provide an up-to-date view of the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.
- Conditions
- Infection
- Keywords
- Diabetic foot infections, microorganisms
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic foot infection | Patients with DM (Diabetes Mellitus) presenting with a diabetic foot infection will be enrolled in the current trial to determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.
Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut MUTLUOGLU, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Vedat Turhan, MD, Study director, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026830
- Sponsor's protocol ID
- TURK-DAY
- Acronym
- TURK-DAY
- Status last verified
- Mar 2015
- First submitted
- 30 Dec 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hatipoglu M, Mutluoglu M, Turhan V, Uzun G, Lipsky BA; Turk-Day Study Group; Sevim E, Demiraslan H, Eryilmaz E, Ozuguz C, Memis A, Ay H, Arda B, Uysal S, Motor VK, Kader C, Erturk A, Coskun O, Duygu F, Guler S, Altay FA, Ogutlu A, Bolukcu S, Yildiz S, Kandemir O, Aslaner H, Polat A, Karahocagil MK, Yasar KK, Sehmen E, Kilic S, Sunbul M, Gencer S, Bozkurt F, Yanik T, Oztoprak N, Batirel A, Sozen H, Kilic I, Celik I, Ay B, Tosun S, Kadanali A, Comoglu S, Denk A, Hosoglu S, Aydin O, Elaldi N, Akalin S, Kandemir B, Akbulut A, Demirdal T, Balik R, Azak E, Sengoz G. Causative pathogens and antibiotic resistance in diabetic foot infections: A prospective multi-center study. J Diabetes Complications. 2016 Jul;30(5):910-6. doi: 10.1016/j.jdiacomp.2016.02.013. Epub 2016 Feb 21.
PubMed 26965794
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microbiologic Profile of Diabetic Foot Infections in Turkey (TURK-DAY): Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT02026830
- Acronym / sponsor ID
- TURK-DAY / TURK-DAY
- Conditions
- Infection
- Keywords
- Diabetic foot infections, microorganisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Jan 2014 (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.
To determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.
Detailed description
Recent studies have demonstrated substantial variation in the etiology of DFIs (Diabetic Foot Infections) in different regions of the world . In contrast to Western countries, studies from Asia and Africa have demonstrated that aerobic gram-negative organisms, particularly Pseudomonas aeruginosa, are far more common . The majority of current guidelines for the management of DFIs have been prepared in Western countries . Based on the results of more recent studies from the Asian continent, however, empiric antibiotic therapy for DFIs may need to be directed at organisms with substantially different antibiotic susceptibility patterns than those recommended in current guidelines. Thus, suggested antibiotic regimens for DFIs should be optimized for local clinical practice. The aim of the current trial is to provide an up-to-date view of the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic foot infection | – | –Patients with DM (Diabetes Mellitus) presenting with a diabetic foot infection will be enrolled in the current trial to determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with DM presenting with a diabetic foot infection will be enrolled in the current trial to determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.
Key inclusion criteria (2 listed)
- Established diagnosis of Diabetes Mellitus
- Diabetic foot wound clinically diagnosed as infected
Key exclusion criteria (1 listed)
- -
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
Causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.
Time frame: 6 months
Questionnaire
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 11 Mar 2015.
- Derived from this study: PubMed 26965794Hatipoglu M, Mutluoglu M, Turhan V, Uzun G, Lipsky BA; Turk-Day Study Group; Sevim E, Demiraslan H, Eryilmaz E, Ozuguz C, Memis A, Ay H, Arda B, Uysal S, Motor VK, Kader C, Erturk A, Coskun O, Duygu F, Guler S, Altay FA, Ogutlu A, Bolukcu S, Yildiz S, Kandemir O, Aslaner H, Polat A, Karahocagil MK, Yasar KK, Sehmen E, Kilic S, Sunbul M, Gencer S, Bozkurt F, Yanik T, Oztoprak N, Batirel A, Sozen H, Kilic I, Celik I, Ay B, Tosun S, Kadanali A, Comoglu S, Denk A, Hosoglu S, Aydin O, Elaldi N, Akalin S, Kandemir B, Akbulut A, Demirdal T, Balik R, Azak E, Sengoz G. Causative pathogens and antibiotic resistance in diabetic foot infections: A prospective multi-center study. J Diabetes Complications. 2016 Jul;30(5):910-6. doi: 10.1016/j.jdiacomp.2016.02.013. Epub 2016 Feb 21.
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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.
Vedat Turhan, MD study director
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
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 Infection, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 2 inclusion and 1 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 11 Mar 2015. 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?
Causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey. (time frame: 6 months). 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 NCT02026830, which also lists 1 linked publication.
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 11 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.