Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01322256
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
2011-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET/CT Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], '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': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C101172', 'term': 'Sulesomab'}, {'id': 'C062942', 'term': "2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole"}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'The study has proven to be infeasible.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2011-03-23', 'studyFirstSubmitQcDate': '2011-03-23', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference between AUCs for PET/CT scan and scintigraphy', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Foot', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': "The investigators' primary objective is to assess the predictive power of PET/CT scanning in the evolution of infectious osteoarthritis of the diabetic diabetic after antibiotic therapy prescribed by national and international recommendations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* Patient has type I or type II diabetes\n* Patient consulting in the department of Metabolic and Endocrine Diseases (Caremeau Hospital) or the department of Nutritional Diseases and Diabetology (Grau de Roi Medical Center) at the Nîmes University Hospital\n* Patient has infected osteoarthritis of the foot according to the International Working Group on the Diabetic Foot with a probability \\> 50% (score \\>= 2).\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* The patient is pregnant\n* The patient is breastfeeding\n* Patient has severe sepsis or a stage 4 infection according to the international consensus on the diabetic foot\n* Patient has severe renal insufficiency as defined by glomerular filtration rate \\< 30ml/min/1.73 m\\^2, calculated according to the MDRD equation, and is not undergoing dialysis\n* Patient has a contra-indication for an MRI\n* pacemaker\n* intracranial clips\n* metallic inclusions\n* severe claustrophobia'}, 'identificationModule': {'nctId': 'NCT01322256', 'acronym': 'ISEOD', 'briefTitle': 'PET/CT Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Positron Emission Tomography - Computed Tomography (PET/CT) Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot', 'orgStudyIdInfo': {'id': 'AOI/2009/SJ-01'}, 'secondaryIdInfos': [{'id': '2010-020160-38', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Included patients', 'description': 'Patients included in the study according to stated inclusion and exclusion criteria\n\nIntervention: Bone scintigraphy Intervention: Leukoscan Intervention: PET / CT Intervention: Bone biopsy Intervention: Bloodwork', 'interventionNames': ['Procedure: Bone scintigraphy', 'Procedure: Leukoscan', 'Procedure: PET / CT', 'Procedure: Bone biopsy', 'Biological: Bloodwork']}], 'interventions': [{'name': 'Bone scintigraphy', 'type': 'PROCEDURE', 'description': 'Bone scintigraphy of the affected area', 'armGroupLabels': ['Included patients']}, {'name': 'Leukoscan', 'type': 'PROCEDURE', 'description': 'Scintigraphy with labeled neutrophils', 'armGroupLabels': ['Included patients']}, {'name': 'PET / CT', 'type': 'PROCEDURE', 'description': 'PET / CT of the affected area', 'armGroupLabels': ['Included patients']}, {'name': 'Bone biopsy', 'type': 'PROCEDURE', 'description': 'A bone biopsy is performed during pre-inclusion work up.', 'armGroupLabels': ['Included patients']}, {'name': 'Bloodwork', 'type': 'BIOLOGICAL', 'description': 'CRP and procalcitonin are measured in the pre-inclusion work up.', 'armGroupLabels': ['Included patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'state': 'Gard', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nîmes', '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}}], 'overallOfficials': [{'name': 'Sophie Schuldiner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}, {'name': 'Nathalie Jourdan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}