CompletedNot Applicable

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

France278 participantsStarted 2010-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 hours

Trial details

NCT IDNCT01212120

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-03-19

View on ClinicalTrials.gov More Diabetic Foot trials