Clinical trial NCT05616351: Antibiotic Therapy in Infections of the Diabetic Foot Syndrome
Official title: Antibiotische Therapie In Infektionen Des Diabetischen Fusssyndroms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Infection
Keywords: diabetic foot syndrome
antibiotic therapy
soft tissue infection
osteomyelitis
bone infection
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: This retrospective study examines the surgical and antibiotic treatment of diabetic foot syndrome infections treated at the University Hospital Basel since 2019.

It 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.

Detailed description: 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.

Inadequate use of antibiotics should thus be recognized. The study has the aspect of quality control.

Eligibility criteria: Inclusion Criteria:

* soft tissue infection or bone infection (incl. osteomyelitis) in diabetic foot syndrome
* inpatient stay at the University Hospital Basel between January 1st, 2019 and December 31st, 2021
* surgical intervention (amputation and/or debridement)
* signed general consent

Exclusion Criteria:

* datasets without a diagnosis of the diabetic foot
* no surgical intervention performed (amputation and/or debridement)
* surgical interventions performed by disciplines other than orthopaedics/traumatology (e.g. vascular surgery)
* infections in osteosynthesis material (implant or fracture-associated infections)

Primary outcomes:
measure: Compliance with the hospital in-house guidelines for diabetic foot infections with regard to antibiotic treatment
timeFrame: one time assessment at baseline
Secondary outcomes:
measure: Duration of antibiotic therapy (days)
timeFrame: one time assessment at baseline
measure: Relapse of diabetic foot infections (number)
timeFrame: one time assessment at baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Orthopedics and Traumatology
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Andreas Marc Müller, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.