Antibiotic Therapy in Infections of the Diabetic Foot Syndrome

Diabetic Foot Infection Clinical Trial

— DFO  

Official title:

Antibiotische Therapie In Infektionen Des Diabetischen Fusssyndroms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05616351
• Other study ID #: 2022-01512; mu22Mueller2
• Status: Completed
• Start date: October 12, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetic Foot
• Diabetic Foot Infection
• Infections

Intervention

Other:
• Data collection in patients with diabetic foot syndrome and infections in the area of the foot
Data collection: on (surgical and antibiotic) treatment and implementation of the recommendations published 2019 with regard to the duration of antibiotic therapy.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Orthopedics and Traumatology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with the hospital in-house guidelines for diabetic foot infections with regard to antibiotic treatment	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.	one time assessment at baseline
Secondary	Duration of antibiotic therapy (days)	Duration of antibiotic therapy	one time assessment at baseline
Secondary	Relapse of diabetic foot infections (number)	Relapse of diabetic foot infections (number)	one time assessment at baseline