Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT01212120
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2010-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The DNA samples correspond to the bacteria present in the nose and feet of diabetic patients.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2012-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2010-09-29', 'studyFirstSubmitQcDate': '2010-09-29', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion.', 'timeFrame': '3 hours', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic foot'], 'conditions': ['Diabetic Foot', 'Staphylococcus Aureus']}, 'referencesModule': {'references': [{'pmid': '27720361', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult type 1 or 2 diabetic patients with grade 2-4 foot or ankle ulcers (first event or recurrence)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 or 2 diabetic patients\n* Patients consulting or hospitalized in the Diabetology departments of one of the participating centers\n* Grade 2-4 ulcer on the foot or ankle (both primo and recurrent events are acceptable)\n\nExclusion Criteria:\n\n* Patient refuses to participate\n* Pregnant, parturient or breastfeeding women\n* Patient does not have diabetic foot or arteritic\n* Diabetic ulcer is located elsewhere than the foot or ankle\n* The ulcer is non-swabbable\n* Patient does not have social-security coverage\n* Patient is under any type of guardianship'}, 'identificationModule': {'nctId': 'NCT01212120', 'briefTitle': 'The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections', 'orgStudyIdInfo': {'id': 'PHRC-I/2009/JPL-02'}, 'secondaryIdInfos': [{'id': '2009-A00849-48', 'type': 'OTHER', 'domain': 'Afssaps, RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients', 'description': 'All patients', 'interventionNames': ['Biological: Genetic profiling of bacterial cultures']}], 'interventions': [{'name': 'Genetic profiling of bacterial cultures', 'type': 'BIOLOGICAL', 'description': 'Genetic profiling of bacterial cultures harvested from both the nose and foot lesions of patients', 'armGroupLabels': ['All patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '30240', 'city': 'Le Grau-du-Roi', 'country': 'France', 'facility': 'CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi', 'geoPoint': {'lat': 43.53881, 'lon': 4.13559}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'APHM - Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU de Montpellier - Hôpital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Jean-Philippe Lavigne, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}