Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000300471
Ethics application status
Approved
Date submitted
4/06/2007
Date registered
5/06/2007
Date last updated
5/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Foot orthoses for foot pain in people with diabetes and peripheral arterial disease
Scientific title
The effect of custom foot orthoses for foot pain in people with diabetes and peripheral arterial disease: A randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
FODPAD trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot pain 1842 0
Diabetes 1843 0
Peripheral arterial disease 1844 0
Condition category
Condition code
Metabolic and Endocrine 1936 1936 0 0
Diabetes
Cardiovascular 1937 1937 0 0
Other cardiovascular diseases
Other 1938 1938 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be conducted to investigate the effectiveness of custom-made foot orthoses (shoe innersoles) on foot pain, plantar pressure loading, functional ability and health related quality of life in people with diabetes mellitus and peripheral arterial disease. Participants will be randomly allocated to either an intervention group (custom foot orthoses/footwear) or a control group. All participants are required to wear there allocated device for 8 weeks.
Intervention code [1] 1802 0
Treatment: Devices
Comparator / control treatment
Control (sham orthoses/footwear).
Control group
Placebo

Outcomes
Primary outcome [1] 2753 0
Foot pain is measured with a questionnaire
Timepoint [1] 2753 0
At baseline and again at 8 weeks.
Secondary outcome [1] 4643 0
Secondary outcomes include plantar pressure, health related quality of life, functional ability, foot comfort, and activity levels.
Timepoint [1] 4643 0
All outcomes will be measured at baseline and again at 8 weeks.

Eligibility
Key inclusion criteria
Subjects diagnosed with diabetes mellitus and peripheral arterial disease and ambulent foot pain.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
wheelchair-bound; foot infection; current foot ulceration; amputation; pregnancy; recent foot trauma; current usage of prescribed foot orthoses; unwilling to wear supplied footwear, or lack of willingness to return for follow-up.

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 by telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants and assessor are blinded to treatment allocation. The administering clinician will not be blinded to participant allocation.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2080 0
Charities/Societies/Foundations
Name [1] 2080 0
Diabetes Australia Research Trust (DART)
Country [1] 2080 0
Australia
Primary sponsor type
Hospital
Name
Podiatry Department, Westmead Hospital
Address
Country
Australia
Secondary sponsor category [1] 1886 0
Hospital
Name [1] 1886 0
Podiatry Department, Westmead Hospital
Address [1] 1886 0
Country [1] 1886 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3871 0
Westmead Hospital
Ethics committee address [1] 3871 0
Ethics committee country [1] 3871 0
Australia
Date submitted for ethics approval [1] 3871 0
Approval date [1] 3871 0
14/05/2007
Ethics approval number [1] 3871 0
07/019

Summary
Brief summary
Foot orthoses customised to an individual have been shown to reduce foot pressure loading, foot ulceration and major amputations in patients with diabetes. However, there is limited evidence of treatment for foot pain in patients with diabetes and peripheral arterial disease at risk of foot ulceration and amputation. In particular, evidence for foot orthoses, which are commonly prescribed for this clinical condition, is lacking and there is an urgent need to evaluate their effect on foot pain, comfort, plantar pressure and health-related quality of life. Indeed, if foot orthoses provide an improved level of patient pain/comfort, the patient is more likely to adhere to prescribed daily levels of walking for exercise therefore improving mobility, function and long term peripheral arterial flow which is critical for patient survival.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27905 0
Address 27905 0
Country 27905 0
Phone 27905 0
Fax 27905 0
Email 27905 0
Contact person for public queries
Name 10991 0
Mr Caleb Wegener
Address 10991 0
Podiatry Department
Level 1, Block E
Westmead Hospital
Po Box 533
Wentworthville, NSW 2145
Country 10991 0
Australia
Phone 10991 0
02 98456918
Fax 10991 0
Email 10991 0
[email protected]
Contact person for scientific queries
Name 1919 0
Dr Joshua Burns
Address 1919 0
Podiatry Department
Level 1
Block E
Westmead Hospital
Po Box 533
Wentworthville NSW 2145
Country 1919 0
Australia
Phone 1919 0
02 98451228
Fax 1919 0
Email 1919 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.