Antibiotic Therapy in Infections of the Diabetic Foot Syndrome

Completed

• Conditions: Diabetic Foot Infection

• Registration Number: NCT05616351
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2022-10-12
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-15
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance with the hospital in-house guidelines for diabetic foot infections with regard to antibiotic treatment	one time assessment at baseline	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.

Secondary Outcome Measures

Name	Time	Method
Duration of antibiotic therapy (days)	one time assessment at baseline	Duration of antibiotic therapy
Relapse of diabetic foot infections (number)	one time assessment at baseline	Relapse of diabetic foot infections (number)

Trial Locations

Locations (1)

University Hospital Basel, Orthopedics and Traumatology; 🇨🇭 Basel, Switzerland