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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 October 2015
Main ID:  NCT02565940
Date of registration: 30/09/2015
Prospective Registration: No
Primary sponsor: Assistance Publique Hopitaux De Marseille
Public title: Study by Metagenomics and Culturomicsapproaches of Bacterial and Viral Flora of Diabetic Foot Infection
Scientific title:
Date of first enrolment: December 2014
Target sample size: 150
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02565940
Study type:  Observational
Study design:  Observational Model: Case-Only, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     desalbres urielle
Address: 
Telephone:
Email:
Affiliation:  Assistance Publique Hopitaux De Marseille
Name:     LEVY PIERRE
Address: 
Telephone:
Email: pierre.levy@ap-hm.fr
Affiliation: 
Name:     levy pierre
Address: 
Telephone:
Email: pierre.levy@ap-hm.fr
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients were taken care by the services(departments) of Diabetology or Infectious
diseases of the CHU(TEACHING HOSPITAL) of Nîmes, were hospitalized or were seen in
consultation and presenting a wound chronicle of the foot and/or the ankle of Rank 2
- 4 (Classification of the IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004], inaugural
or récidivante.

Exclusion Criteria:

- The patient participates in another study

- The patient is in period of exclusion determined by a previous study

- The patient is under protection(saving) of justice, under guardianship or under
guardianship

- The patient refuses to sign the consent

- It turns out impossible to give about the lit(enlightened) information

- The patient is pregnant, parturiente, or she breast-feeds

- The patients having no wound

- The patients diabetics having a wound chronicles of Rank 1 (Classification of the
IWGDF) [IWGDF, Lipsky Clin Infect Dis on 2004]



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Diabetic Foot Infection
Intervention(s)
Other: biopsy
Primary Outcome(s)
dermal sample [Time Frame: 36 months]
Secondary Outcome(s)
Secondary ID(s)
2014-35
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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