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Trial registered on ANZCTR
Registration number
ACTRN12625000526471p
Ethics application status
Submitted, not yet approved
Date submitted
13/04/2025
Date registered
26/05/2025
Date last updated
26/05/2025
Date data sharing statement initially provided
26/05/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Exercise for diabetes-related foot wounds
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Scientific title
Exercise for diabetes-related foot wounds: A randomised feasibility trial
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Secondary ID [1]
314191
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MRFCDDM000062
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes-related foot wounds
337055
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Condition category
Condition code
Metabolic and Endocrine
333499
333499
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0
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Diabetes
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Physical Medicine / Rehabilitation
333589
333589
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
An individualised 12-week exercise program supervised by an Accredited Exercise Physiologist delivered three times a week at a face-to-face appointment.
Each exercise session will last for a approximately 30 minutes and will involve a 5-minute warm-up followed by 10 minutes of aerobic exercise (e.g. limb cycling), 10 minutes of resistance exercises (e.g., chest press and leg curls) and then a 5-minute a cool-down. Exercise intensity will be monitored and gradually increased using a perceived exertion scale (Borg’s scale).
All exercises will be tailored to the participant's need and will include lower limb exercises where possible. Attendance, participation and safety will be documented at the end of every session.
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Intervention code [1]
330793
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Treatment: Other
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Comparator / control treatment
Standard podiatry care and medical care in line with International Working Group on the Diabetic Foot (IWGDF) Guidelines
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Control group
Active
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Outcomes
Primary outcome [1]
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Safety
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Assessment method [1]
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Audit study records of intervention safety (number and type of adverse events per session attended). Examples of possible adverse events may include injury, muscle soreness and a hypoglycaemic event.
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Timepoint [1]
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Weekly during the 12-week intervention
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Primary outcome [2]
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Feasibility (participant recruitment)
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Assessment method [2]
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Participant recruitment rate: Audit study records of the number of participants who who enrolled from those who met the eligibility criteria and were invited to take part in the study.
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Timepoint [2]
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Baseline
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Primary outcome [3]
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Feasibility (acceptability)
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Assessment method [3]
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Participant evaluation survey (designed specifically for this study) with open-ended and Likert scale questions
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Timepoint [3]
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At the end of the 12-week intervention
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Secondary outcome [1]
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Wound healing
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Assessment method [1]
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Ruler estimation or software imaging as available
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Timepoint [1]
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Baseline, 12-week follow-up and 24-week follow-up post-commencement of intervention
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Secondary outcome [2]
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Physical function
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Assessment method [2]
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Grip strength, 6MWT, Berg Balance Scale, TUG, 30-sec chair stand test. Assessed as a composite outcome of physical function, with separate scoring for each of the assessments
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Timepoint [2]
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Baseline, 12-week follow-up and 24-week follow-up post-commencement of intervention
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Secondary outcome [3]
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Diabetes management
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Assessment method [3]
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Blood glucose control (HbA1c)
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Timepoint [3]
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Baseline, 12-week follow-up and 24-week follow-up post-commencement of intervention
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Secondary outcome [4]
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Wellbeing
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Assessment method [4]
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WHO-5
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Timepoint [4]
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Baseline, 12-week follow-up and 24-week follow-up post-commencement of intervention
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Secondary outcome [5]
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Quality of life
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Assessment method [5]
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EQ-5D
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Timepoint [5]
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Baseline, 12-week follow-up and 24-week follow-up post-commencement of intervention
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Secondary outcome [6]
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Anxiety
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Assessment method [6]
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Hospital Anxiety and Depression Scale (HADS-A [Anxiety])
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Timepoint [6]
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Baseline, 12-week follow-up and 24-week follow-up post-commencement of intervention.
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Secondary outcome [7]
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Frailty
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Assessment method [7]
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Frail scale
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Timepoint [7]
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Baseline, 12-week follow-up and 24-week follow-up post-commencement of intervention.
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Secondary outcome [8]
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Depression
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Assessment method [8]
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Hospital Anxiety and Depression Scale (HADS-D [Depression])
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Timepoint [8]
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Baseline, 12-week follow-up and 24-week follow-up post-commencement of intervention.
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Secondary outcome [9]
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PRIMARY OUTCOME: Feasibility (participant engagement)
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Assessment method [9]
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Audit study records of participant adherence to the exercise program (e.g. number of sessions attended each week of the 12-week program)
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Timepoint [9]
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Baseline, 12-week follow-up and 24-week follow-up post-commencement of intervention
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Secondary outcome [10]
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PRIMARY OUTCOME: Feasibility (participant retention)
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Assessment method [10]
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Audit study records of the number of participants remaining in the study at follow-up assessments relative to the number of recruited participants
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Timepoint [10]
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12-week follow-up and 24-week follow-up post-commencement of intervention
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Eligibility
Key inclusion criteria
People with a diabetes-related foot wound
Wound, Ischemia, and Foot Infection (WIfI) wound score equal or greater than 1
Able to understand English to provide informed consent and complete questionnaires.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Foot ulcer in the absence of diabetes
Active infection with systemic symptoms
TCPO2 or Toe Pressures <30mmHg and requiring surgery.
Surgical wounds (<4weeks)
Patients requiring a wheelchair on a regular basis.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 randomisation stratified according to wound type
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
Analysis of feasibility measures will be analysed descriptively
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
1/07/2026
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Actual
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Date of last data collection
Anticipated
16/12/2026
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Government Department of Health and Aged Care: The Medical Research Future Fund (MRFF) Targeted Translation Research Accelerator – Cardiovascular Disease and Diabetes Mechanisms grant opportunity
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Address [1]
318443
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Country [1]
318443
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Australia
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Primary sponsor type
University
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Name
University of South Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
320839
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Government body
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Name [1]
320839
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Central Adelaide Local Health Network Inc
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Address [1]
320839
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Country [1]
320839
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317061
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
317061
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
317061
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Australia
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Date submitted for ethics approval [1]
317061
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17/03/2025
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Approval date [1]
317061
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Ethics approval number [1]
317061
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Summary
Brief summary
This randomised feasibility trial aims to assess the potential and feasibility of an individualised 12-week exercise program supervised by an Accredited Exercise Physiologist, embedded within an existing healthcare service.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Lisa Matricciani
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Address
139870
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University of South Australia, City East, North Terrace, Adelaide, SA, 5000
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Country
139870
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Australia
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Phone
139870
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+61 8 83025993
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Fax
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Email
139870
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[email protected]
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Contact person for public queries
Name
139871
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Lisa Matricciani
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Address
139871
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University of South Australia, City East, North Terrace, Adelaide, SA, 5000
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Country
139871
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Australia
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Phone
139871
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+61 8 83025993
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Fax
139871
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Email
139871
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[email protected]
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Contact person for scientific queries
Name
139872
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Lisa Matricciani
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Address
139872
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University of South Australia, City East, North Terrace, Adelaide, SA, 5000
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Country
139872
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Australia
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Phone
139872
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+61 8 83025993
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Fax
139872
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Email
139872
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
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.
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