Antibiotic Therapy in Infections of the Diabetic Foot Syndrome (DFO)

Antibiotische Therapie In Infektionen Des Diabetischen Fusssyndroms

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Infection
• Intervention / Treatment: Other: Data collection in patients with diabetic foot syndrome and infections in the area of the foot

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Orthopedics and Traumatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of antibiotic therapy (days)	Duration of antibiotic therapy	one time assessment at baseline
Relapse of diabetic foot infections (number)	Relapse of diabetic foot infections (number)	one time assessment at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Andreas Marc Müller, Prof. Dr. med., Department of Orthopaedics and Traumatology, University Hospital Basel

Publications and helpful links

General Publications

• 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. Journal of Bone and Joint Infection. 2024; 9: 183-190.

Helpful Links

• Link to citation

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: osteomyelitis; antibiotic therapy; soft tissue infection; diabetic foot syndrome; bone infection
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Disease Attributes; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot; Infections; Communicable Diseases
• Other Study ID Numbers: 2022-01512; mu22Mueller2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No