Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05616351
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2022-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antibiotic Therapy in Infections of the Diabetic Foot Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018461', 'term': 'Soft Tissue Infections'}, {'id': 'D010019', 'term': 'Osteomyelitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance with the hospital in-house guidelines for diabetic foot infections with regard to antibiotic treatment', 'timeFrame': 'one time assessment at baseline', 'description': 'Implementation of the guidelines published in 2019 with regard to antibiotic therapy in diabetic foot infections, taking into account clinical, microbiological and histopathological criteria. The defined endpoints are (i) fully compliant with internal policies, (ii) partially compliant with internal policies, and (iii) not compliant with internal policies.'}], 'secondaryOutcomes': [{'measure': 'Duration of antibiotic therapy (days)', 'timeFrame': 'one time assessment at baseline', 'description': 'Duration of antibiotic therapy'}, {'measure': 'Relapse of diabetic foot infections (number)', 'timeFrame': 'one time assessment at baseline', 'description': 'Relapse of diabetic foot infections (number)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic foot syndrome', 'antibiotic therapy', 'soft tissue infection', 'osteomyelitis', 'bone infection'], 'conditions': ['Diabetic Foot Infection']}, 'referencesModule': {'references': [{'pmid': '39040989', 'type': 'RESULT', 'citation': 'Reinert N, Wetzel K, Franzeck F, Morgenstern M, Aschwanden M, Wolff T, Clauss M, Sendi P. What is the agreement between principles and practice of antibiotic stewardship in the management of diabetic foot infection: an in-hospital quality control study. J Bone Jt Infect. 2024 Jun 28;9(3):183-190. doi: 10.5194/jbji-9-183-2024. eCollection 2024.'}], 'seeAlsoLinks': [{'url': 'https://jbji.copernicus.org/articles/9/183/2024/jbji-9-183-2024.pdf', 'label': 'Link to citation'}]}, 'descriptionModule': {'briefSummary': 'This retrospective study examines the surgical and antibiotic treatment of diabetic foot syndrome infections treated at the University Hospital Basel since 2019.\n\nIt analyses the implementation of the hospital in-house guidelines published in 2019 with regard to antibiotic therapy in diabetic foot infections, taking into account clinical, microbiological and histopathological criteria. The defined endpoints are (i) fully compliant with internal policies, (ii) partially compliant with internal policies, and (iii) not compliant with internal policies. The recording of these proportions is descriptive.', 'detailedDescription': "This retrospective study examines the surgical and antibiotic treatment of diabetic foot syndrome infections treated at the University Hospital Basel since 2019. (In 2019 the departments of infectiology and orthopedics at the University Hospital Basel published recommendations with regard to the duration of antibiotic therapy in infections of the diabetic foot syndrome. This depends on whether a surgical intervention was performed and takes into account both the microbiological and the histopathological samples). Data that are routinely collected in everyday clinical practice and stored in the hospitals' medical records will be evaluated. The aim of this research project is to check the implementation of these recommendations.\n\nInadequate use of antibiotics should thus be recognized. The study has the aspect of quality control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The data in this retrospective study derive from everyday clinical work, collected between January 1st, 2019 and December 31st, 2021 at the Department of Infectiology and Department of Orthopaedics and Traumatology at the University Hospital Basel.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* soft tissue infection or bone infection (incl. osteomyelitis) in diabetic foot syndrome\n* inpatient stay at the University Hospital Basel between January 1st, 2019 and December 31st, 2021\n* surgical intervention (amputation and/or debridement)\n* signed general consent\n\nExclusion Criteria:\n\n* datasets without a diagnosis of the diabetic foot\n* no surgical intervention performed (amputation and/or debridement)\n* surgical interventions performed by disciplines other than orthopaedics/traumatology (e.g. vascular surgery)\n* infections in osteosynthesis material (implant or fracture-associated infections)'}, 'identificationModule': {'nctId': 'NCT05616351', 'acronym': 'DFO', 'briefTitle': 'Antibiotic Therapy in Infections of the Diabetic Foot Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Antibiotische Therapie In Infektionen Des Diabetischen Fusssyndroms', 'orgStudyIdInfo': {'id': '2022-01512; mu22Mueller2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Data collection in patients with diabetic foot syndrome and infections in the area of the foot', 'type': 'OTHER', 'description': 'Data collection: on (surgical and antibiotic) treatment and implementation of the recommendations published 2019 with regard to the duration of antibiotic therapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Orthopedics and Traumatology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Andreas Marc Müller, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedics and Traumatology, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}