Diabetic FootNCT01212120
The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
An observational study of Diabetic Foot and Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Staphylococcus Aureus
- What is being tested?
- Genetic profiling of bacterial cultures
- How many people
- 278 participants
- Where
- 4 sitesFrance
- Study dates
- Sep 2010to 19 Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult type 1 or 2 diabetic patients with grade 2-4 foot or ankle ulcers (first event or recurrence)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
Le Grau-du-Roi, 30240
APHM - Hôpital Nord
Marseille, 13915
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, Gard, 30029
About this study
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
- Being tested
- Genetic profiling of bacterial cultures
- Keywords
- Diabetic foot
- Medical subject headings
- Diabetic Foot, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic profiling of bacterial culturesBiological
Genetic profiling of bacterial cultures harvested from both the nose and foot lesions of patients
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients Receives: Biological: Genetic profiling of bacterial cultures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startSep 2010
- Primary completion19 Mar 2012
- Study completion19 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Lavigne, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212120
- Sponsor's protocol ID
- PHRC-I/2009/JPL-02
- Other IDs
- 2009-A00849-48
- Status last verified
- Mar 2015
- First submitted
- 29 Sep 2010
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27720361
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
- ClinicalTrials.gov ID
- NCT01212120
- Acronym / sponsor ID
- PHRC-I/2009/JPL-02
- Conditions
- Diabetic Foot, Staphylococcus Aureus
- Keywords
- Diabetic foot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Sep 2010
- Primary completion
- 19 Mar 2012 (actual)
- Study completion
- 19 Mar 2012 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Biological: Genetic profiling of bacterial culturesAll patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult type 1 or 2 diabetic patients with grade 2-4 foot or ankle ulcers (first event or recurrence)
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic profiling of bacterial culturesGenetic profiling of bacterial cultures harvested from both the nose and foot lesions of patients | Biological | All patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 27720361Dunyach-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe Lavigne, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Staphylococcus Aureus, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion. (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.