Study by Metagenomics and Culturomicsapproaches of Bacterial and Viral Flora of Diabetic Foot Infection

NCT02565940 | Unknown

• 1 other identifier: 2014-35
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the most frequent new species frequency in the disease and incidentally get a sense of their role in the evolution and prognosis of the disease, including failures of and targeted antibiotic therapy on all 150 samples.

Conditions

Diabetic Foot Infection

Outcome Measures

Primary Outcomes (1)

• dermal sample

  36 months

Study Arms (1)

diabetic patient with foot infection

Other: biopsy

Interventions

biopsy OTHER

diabetic patient with foot infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

diabetic patient with foot infection

You may qualify if:

• 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.

You may not qualify if:

• The patient participates in another 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) \[IWGDF, Lipsky Clin Infect Dis on 2004\]

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, Paca, 13354, France

RECRUITING

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• desalbres urielle

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

levy pierre

CONTACT

pierre.levy@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 1, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

FR (1)