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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

278 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-03-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Foot Staphylococcus Aureus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

Genetic profiling of bacterial cultures

Intervention Type BIOLOGICAL

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

Interventions

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Genetic profiling of bacterial cultures

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No