NCT02026830

Brief Summary

To determine the causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
447

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

December 30, 2013

Last Update Submit

March 10, 2015

Conditions

Keywords

Diabetic foot infectionsmicroorganisms

Outcome Measures

Primary Outcomes (1)

  • Causative microorganisms and their antibiotic sensitivity patterns in diabetic patients with a foot infection in Turkey.

    Questionnaire

    6 months

Study Arms (1)

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.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Established diagnosis of Diabetes Mellitus
  • Diabetic foot wound clinically diagnosed as infected

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GATA Haydarpasa Egitim Hastanesi

Istanbul, No State Required, 34068, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Infections

Study Officials

  • Vedat Turhan, MD

    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor

Study Record Dates

First Submitted

December 30, 2013

First Posted

January 3, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations