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.

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Key information

Conditions

Diabetic Foot Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Gram-Positive Bacterial Infections Infections Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcus Aureus Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, Gard, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genetic profiling of bacterial cultures

Biological

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

Primary outcomes

Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Sep 30, 2010
Registry last updated: Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed