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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212120
• Other study ID #: PHRC-I/2009/JPL-02
• Secondary ID: 2009-A00849-48
• Status: Completed
• Phase: N/A
• First received: September 29, 2010
• Last updated: March 26, 2015
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Foot
• Staphylococcus Aureus

Intervention

Biological:
• Genetic profiling of bacterial cultures
Genetic profiling of bacterial cultures harvested from both the nose and foot lesions of patients

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi	Le Grau du Roi
France	APHM - Hôpital Nord	Marseille
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nimes	Gard

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion.	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.	3 hours	No