The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01212120
First received: September 29, 2010
Last updated: March 3, 2014
Last verified: March 2014

September 29, 2010
March 3, 2014
September 2010
March 2012   (final data collection date for primary outcome measure)
Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion. [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion. Genetic profiles do not change with time. This is a transversal, pinpoint measure.
Same as current
Complete list of historical versions of study NCT01212120 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections

The presence of S aureus in the nasal passages of diabetic patients may be a risk factor for diabetic foot lesion infections. Our aim is to compare the genetic profiles of S aureus strains found in the noses and on the foot lesions of diabetic patients. The investigators are also studying the virulence of these strains, the prevalance of S aureus at either site, and whether or not the quantity of S aureus found in the nose affects the risk for infection in foot lesions. The investigators also use this study to test the sensitivity and specificity of the GeneXpert system.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

The DNA samples correspond to the bacteria present in the nose and feet of diabetic patients.

Non-Probability Sample

Adult type 1 or 2 diabetic patients with grade 2-4 foot or ankle ulcers (first event or recurrence)

  • Diabetic Foot
  • Staphylococcus Aureus
Biological: Genetic profiling of bacterial cultures
Genetic profiling of bacterial cultures harvested from both the nose and foot lesions of patients
All patients
All patients
Intervention: Biological: Genetic profiling of bacterial cultures
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 or 2 diabetic patients
  • Patients consulting or hospitalized in the Diabetology departments of one of the participating centers
  • Grade 2-4 ulcer on the foot or ankle (both primo and recurrent events are acceptable)

Exclusion Criteria:

  • Patient refuses to participate
  • Pregnant, parturient or breastfeeding women
  • Patient does not have diabetic foot or arteritic
  • Diabetic ulcer is located elsewhere than the foot or ankle
  • The ulcer is non-swabbable
  • Patient does not have social-security coverage
  • Patient is under any type of guardianship
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01212120
PHRC-I/2009/JPL-02, 2009-A00849-48
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Jean-Philippe Lavigne, MD PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP