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

NCT01212120 | Completed

• 2 other identifiers: PHRC-I/2009/JPL-022009-A00849-48
• Study Type: observational
• Target: 278
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetic Foot; Staphylococcus Aureus

Keywords

Diabetic foot

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All patients

All patients

Biological: Genetic profiling of bacterial cultures

Interventions

Genetic profiling of bacterial cultures BIOLOGICAL

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

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (4)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi

Le Grau-du-Roi, 30240, France

Location

APHM - Hôpital Nord

Marseille, 13915, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

Related Publications (1)

• Dunyach-Remy C, Courtais-Coulon C, DeMattei C, Jourdan N, Schuldiner S, Sultan A, Carriere C, Alonso S, Sotto A, Lavigne JP. Link between nasal carriage of Staphylococcus aureus and infected diabetic foot ulcers. Diabetes Metab. 2017 Apr;43(2):167-171. doi: 10.1016/j.diabet.2016.09.003. Epub 2016 Oct 5.

  PMID: 27720361 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Diabetic Foot; Staphylococcal Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean-Philippe Lavigne, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: September 1, 2010
• Primary Completion: March 19, 2012
• Study Completion: March 19, 2012
• Last Updated: November 17, 2025

Record last verified: 2015-03

Locations

FR (4)