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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01212120

Enrollment

278

Registered

2010-09-30

Start date

2010-09-30

Completion date

2012-03-19

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot, Staphylococcus Aureus

Keywords

Diabetic foot

Brief 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.

Interventions

BIOLOGICALGenetic profiling of bacterial cultures

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion.	3 hours	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026