Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000426583
Ethics application status
Not yet submitted
Date submitted
30/09/2006
Date registered
3/10/2006
Date last updated
3/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non-weight bearing exercise in people with diabetes and foot complications
Scientific title
A structured, non weight bearing exercise program to improve glycaemic control, wound healing and quality of life in people with foot complications due to diabetes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic foot ulcers 1398 0
Condition category
Condition code
Metabolic and Endocrine 1490 1490 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will be undertaking non-weight-bearing exercise three times a week over 20 weeks. The exercise will include resistance training and cardiovascular activities, however these will be undertaken without plantar foot pressure occuring.
Intervention code [1] 1384 0
Treatment: Other
Comparator / control treatment
The control group will be continuing as they have been - no intervention.
Control group
Active

Outcomes
Primary outcome [1] 2061 0
Wound healing rate
Timepoint [1] 2061 0
Measured at week 0, and every 4 weeks until healed or until week 20 (whichever occurs first).
Secondary outcome [1] 3550 0
HbA1c, body mass index
Timepoint [1] 3550 0
Measured week 0, week 10 and week 20.
Secondary outcome [2] 3551 0
Quality of life
Timepoint [2] 3551 0
Assessed at week 0 and week 20.
Secondary outcome [3] 3552 0
Wound substrate changes
Timepoint [3] 3552 0
Measured at week 0 and just prior to healing or week 20, whichever comes first.

Eligibility
Key inclusion criteria
All attending the Austin Health’s High Risk Foot Clinic (HRFC) with a chronic (> six weeks) foot ulcer and diabetes that are physically capable of undertaking exercise, as decided by local medical officer, endocrinologist and/or research exercise physiologist.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with diagnosed osteomyelitis; Patients with frank gangrene;Patients who are unlikely to survive for the duration of the study, such as those who have very low creatinine clearance, and those with advanced malignant cancer;Patients involved in any study affecting glycaemic control, or any factors that could affect wound healing.

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)
sealed opaque envelopes will be used to allocate participants into the groups
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
from a random number table using excel
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1627 0
Charities/Societies/Foundations
Name [1] 1627 0
Austin Hospital Medical Research Foundation
Country [1] 1627 0
Australia
Funding source category [2] 1628 0
Charities/Societies/Foundations
Name [2] 1628 0
Diabetes Australia
Country [2] 1628 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 1428 0
None
Name [1] 1428 0
N/A
Address [1] 1428 0
Country [1] 1428 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3074 0
Heidelberg Repatriation Hospital, Austin Health
Ethics committee address [1] 3074 0
Ethics committee country [1] 3074 0
Australia
Date submitted for ethics approval [1] 3074 0
Approval date [1] 3074 0
Ethics approval number [1] 3074 0

Summary
Brief summary
We aim to assess whether undertaking a structured, non-weightbearing exercise program over 20 weeks will accelerate healing in people with chronic diabetic foot ulcers. We also aim to assess whether this program improves glycaemic control, body mass index, wound bed substrate and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27611 0
Address 27611 0
Country 27611 0
Phone 27611 0
Fax 27611 0
Email 27611 0
Contact person for public queries
Name 10573 0
Dr Rajna Ogrin
Address 10573 0
Podiatry Department
Heidelberg Repatriation Hospital
PO Box 5444
Heidelberg West VIC 3081
Country 10573 0
Australia
Phone 10573 0
+61 3 94962017/2986
Fax 10573 0
+61 3 94962097
Email 10573 0
[email protected]
Contact person for scientific queries
Name 1501 0
Dr Rajna Ogrin
Address 1501 0
Podiatry Department
Heidelberg Repatriation Hospital
PO Box 5444
Heidelberg West VIC 3081
Country 1501 0
Australia
Phone 1501 0
+61 3 94962017/2986
Fax 1501 0
+61 3 94962097
Email 1501 0
[email protected]

No information has been provided regarding IPD availability


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.