Diabetic Foot InfectionDFONCT05616351
Antibiotic Therapy in Infections of the Diabetic Foot Syndrome
An observational study of Diabetic Foot Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infection
- What is being tested?
- Data collection in patients with diabetic foot syndrome and infections in the area of the foot
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Oct 2022to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Orthopedics and Traumatology
Basel, 4031
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot Infection
- Being tested
- Data collection in patients with diabetic foot syndrome and infections in the area of the foot
- Keywords
- diabetic foot syndrome, antibiotic therapy, soft tissue infection, osteomyelitis, bone infection
- Medical subject headings
- Soft Tissue Infections, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection in patients with diabetic foot syndrome and infections in the area of the footOther
Data collection: on (surgical and antibiotic) treatment and implementation of the recommendations published 2019 with regard to the duration of antibiotic therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one time assessment at baseline
Secondary outcomes (2)
Duration of antibiotic therapy (days)
Duration of antibiotic therapy
Measured: one time assessment at baseline
Relapse of diabetic foot infections (number)
Relapse of diabetic foot infections (number)
Measured: one time assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start12 Oct 2022
- Primary completion31 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Marc Müller, Prof. Dr. med., Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616351
- Sponsor's protocol ID
- 2022-01512; mu22Mueller2
- Acronym
- DFO
- Status last verified
- Jul 2024
- First submitted
- 7 Nov 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. J Bone Jt Infect. 2024 Jun 28;9(3):183-190. doi: 10.5194/jbji-9-183-2024. eCollection 2024.
PubMed 39040989
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotische Therapie In Infektionen Des Diabetischen Fusssyndroms
- ClinicalTrials.gov ID
- NCT05616351
- Acronym / sponsor ID
- DFO / 2022-01512; mu22Mueller2
- Conditions
- Diabetic Foot Infection
- Keywords
- diabetic foot syndrome, antibiotic therapy, soft tissue infection, osteomyelitis, bone infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection in patients with diabetic foot syndrome and infections in the area of the footData collection: on (surgical and antibiotic) treatment and implementation of the recommendations published 2019 with regard to the duration of antibiotic therapy. | Other | – |
Primary outcome
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.
2 secondary outcomes
Duration of antibiotic therapy (days)
Time frame: one time assessment at baseline
Relapse of diabetic foot infections (number)
Time frame: one time assessment at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Results publication: PubMed 39040989Reinert 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.
- Link to citationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Marc Müller, Prof. Dr. med. principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with the hospital in-house guidelines for diabetic foot infections with regard to antibiotic treatment (time frame: one time assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05616351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.