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Completed

NCT Number: NCT05616351

Antibiotic Therapy in Infections of the Diabetic Foot Syndrome

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.

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Key information

Conditions

Diabetic Foot Infection Bone Diseases Bone Diseases, Infectious Infections Musculoskeletal Diseases Osteomyelitis Soft Tissue Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Orthopedics and Traumatology

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Data collection in patients with diabetic foot syndrome and infections in the area of the foot

Other

Data collection: on (surgical and antibiotic) treatment and implementation of the recommendations published 2019 with regard to the duration of antibiotic therapy.

Primary outcomes

  1. Compliance with the hospital in-house guidelines for diabetic foot infections with regard to antibiotic treatment

    Time frame: 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 outcomes

  1. Duration of antibiotic therapy (days)

    Time frame: one time assessment at baseline

    Duration of antibiotic therapy

  2. Relapse of diabetic foot infections (number)

    Time frame: one time assessment at baseline

    Relapse of diabetic foot infections (number)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Antibiotische Therapie In Infektionen Des Diabetischen Fusssyndroms

Acronym: DFO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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