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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 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Diabetic Foot
Staphylococcus Aureus
 Biological: Genetic profiling of bacterial cultures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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


Enrollment: 278
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients
All patients
 Biological: Genetic profiling of bacterial cultures
Genetic profiling of bacterial cultures harvested from both the nose and foot lesions of patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212120

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nimes, Gard, France, 30029
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau du Roi, France, 30240
APHM - Hôpital Nord
Marseille, France, 13915
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34295
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Jean-Philippe Lavigne, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01212120     History of Changes
Other Study ID Numbers: PHRC-I/2009/JPL-02, 2009-A00849-48
Study First Received: September 29, 2010
Last Updated: March 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Diabetic foot

Additional relevant MeSH terms:
Staphylococcal Infections
Diabetic Foot
Gram-Positive Bacterial Infections
Bacterial Infections
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
 Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 23, 2013