Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000266561
Ethics application status
Approved
Date submitted
16/02/2024
Date registered
15/03/2024
Date last updated
7/04/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial assessing antibiotic duration in diabetic foot ulcers that probe to bone
Scientific title
Pilot randomised controlled trial of feasibility and safety in probe-to-bone diabetic foot ulcer antibiotic therapy
Secondary ID [1] 310887 0
PROBE-DFU trial
Universal Trial Number (UTN)
Trial acronym
PROBE-DFU trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetic foot ulcer 331940 0
Condition category
Condition code
Infection 328666 328666 0 0
Studies of infection and infectious agents
Metabolic and Endocrine 328667 328667 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Probe-to-bone test procedure
-Bedside clinical test performed by inserting a blunt metal probe into an ulcer and palpating for bone at the base
-This test will be performed by a trained clinician (podiatrist or experienced doctor) at initial assessment
-Antibiotic therapy will be commenced as soon as possible after a positive result (ideally on the same day)

Intervention group: 2 weeks antibiotic therapy
-Antibiotic therapy, including agent, dosing and route of administration, will be at the discretion of the treating clinicians based on results of any relevant microbiological culture and susceptibility results, such as wound swab cultures.
-Common antibiotic regimens likely to be used will include oral glucloxacillin 500mg QID, oral Amoxicillin/clavulanate 800/125mg BD, oral Clindamycin 450mg TDS, etc
-Adherence will be assessed via a medication adherence questionnaire given to the patient at each follow-up visit. This questionnaire is specifically designed for this study by the investigators
Intervention code [1] 327310 0
Treatment: Drugs
Comparator / control treatment
Control group: 6 weeks antibiotic therapy
-Antibiotic therapy, including agent, dosing and route of administration, will be at the discretion of the treating clinicians based on results of any relevant microbiological culture and susceptibility results, such as wound swab cultures.
-Common antibiotic regimens likely to be used will include oral glucloxacillin 500mg QID, oral Amoxicillin/clavulanate 800/125mg BD, oral Clindamycin 450mg TDS, etc
-Adherence will be assessed via a medication adherence questionnaire given to the patient at each follow-up visit. This questionnaire is specifically designed for this study by the investigators.
Control group
Active

Outcomes
Primary outcome [1] 336464 0
Eligibility to recruitment ratio
Timepoint [1] 336464 0
End of recruitment period (18 months)
Primary outcome [2] 336465 0
Retention rate
Timepoint [2] 336465 0
End of recruitment period (18 months)
Primary outcome [3] 336466 0
Adherence to protocol
Timepoint [3] 336466 0
End of recruitment period (18 months)
Secondary outcome [1] 428486 0
Recommencement of antibiotic therapy
Timepoint [1] 428486 0
90 days post-initial baseline assessment
Secondary outcome [2] 428487 0
Need for surgical management
Timepoint [2] 428487 0
90 days post-initial baseline assessment
Secondary outcome [3] 428488 0
Continuation of antibiotics
Timepoint [3] 428488 0
14 days, 42 days, 90 days post-initial baseline assessment
Secondary outcome [4] 428489 0
Radiological changes
Timepoint [4] 428489 0
Day 14, Day 42 post-initial baseline assessment

Eligibility
Key inclusion criteria
-Adult patient (greater than or equal to 18 years) with diabetic foot ulcer
-Ulcer with positive probe-to-bone test
-X-ray performed within 72 hours of enrollment demonstrating no changes suggestive of osteomyelitis at the site of the ulcer by the reporting radiologist
-Willing and able to consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Systemic antimicrobial therapy for >7 days in the 30 days prior to initial enrollment
-Systemic signs of sepsis based on SIRS criteria
-Initial surgical therapy deemed more appropriate than medical management alone of diabetic foot infection
-Known pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via REDCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2024
Actual
21/03/2024
Date of last participant enrolment
Anticipated
18/10/2025
Actual
Date of last data collection
Anticipated
18/01/2026
Actual
Sample size
Target
120
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315145 0
Hospital
Name [1] 315145 0
Department of Infectious Diseases and Immunology, Austin Health
Country [1] 315145 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 318108 0
None
Name [1] 318108 0
Address [1] 318108 0
Country [1] 318108 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314083 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 314083 0
https://www.austin.org.au/Office-for-Research/
Ethics committee country [1] 314083 0
Australia
Date submitted for ethics approval [1] 314083 0
11/12/2023
Approval date [1] 314083 0
15/02/2024
Ethics approval number [1] 314083 0

Summary
Brief summary
Probe-to-bone test (PTB) is a simple bedside clinical test to aid in the diagnosis of diabetic foot osteomyelitis (OM). While it has been shown to be useful (especially in a high-risk cohort), diagnosis of OM is supported by additional tests such as X-rays and blood tests for markers of infection. The gold standard test for diagnosing OM is a bone biopsy, which is often not routinely performed due to the invasiveness of the procedure and the difficulty with accessing clinicians trained in performing this. Patients with diabetic foot ulcers and positive PTB tests are often treated for OM with prolonged courses of antibiotics despite normal X-rays and/or normal biomarkers of infection.
This study aims to evaluate the safety and feasibility of treating patients with diabetic foot ulcers and positive PTB test with shorter courses of antibiotic therapy in a low-risk (outpatient) setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130350 0
Prof Jason Trubiano
Address 130350 0
Department of Infectious Diseases, Austin Health, 145 Studley Road, Heidelberg, Victoria - 3084
Country 130350 0
Australia
Phone 130350 0
+61 3 94966676
Fax 130350 0
Email 130350 0
jason.trubiano@austin.org.au
Contact person for public queries
Name 130351 0
Satwik Motaganahalli
Address 130351 0
Department of Infectious Diseases, Austin Health, 145 Studley Road, Heidelberg, Victoria - 3084
Country 130351 0
Australia
Phone 130351 0
+61 3 94964573
Fax 130351 0
Email 130351 0
satwik.motaganahalli@austin.org.au
Contact person for scientific queries
Name 130352 0
Satwik Motaganahalli
Address 130352 0
Department of Infectious Diseases, Austin Health, 145 Studley Road, Heidelberg, Victoria - 3084
Country 130352 0
Australia
Phone 130352 0
+61 3 94964573
Fax 130352 0
Email 130352 0
satwik.motaganahalli@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21667Study protocol  satwik.motaganahalli@austin.org.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.