Antibiotic Therapy in Infections of the Diabetic Foot Syndrome

NCT05616351 | Completed

• 1 other identifier: 2022-01512; mu22Mueller2
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Infection

Keywords

diabetic foot syndrome; antibiotic therapy; soft tissue infection; osteomyelitis; bone infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Duration of antibiotic therapy (days)

  one time assessment at baseline

• Relapse of diabetic foot infections (number)

  one time assessment at baseline

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Orthopedics and Traumatology

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39040989 RESULT

Related Links

• Link to citation

MeSH Terms

Conditions

Soft Tissue Infections; Osteomyelitis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Infections; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andreas Marc Müller, Prof. Dr. med.

  Department of Orthopaedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: October 12, 2022
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

CH (1)