Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614001140640
Ethics application status
Approved
Date submitted
10/10/2014
Date registered
28/10/2014
Date last updated
28/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational study to evaluate foot and ankle characteristics in people with gout and/or diabetes
Scientific title
An observational study to evaluate foot pain and foot-related disability in people with gout and/or diabetes
Secondary ID [1] 285476 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 293253 0
Diabetes 293254 0
Condition category
Condition code
Musculoskeletal 293524 293524 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 293525 293525 0 0
Diabetes
Physical Medicine / Rehabilitation 293569 293569 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this observational study we are observing a series of primary outcomes: Foot pain, foot related disability and walking velocity.
Secondary outcomes are: global pain, global well-being, functional ability and lower limb function.
We are looking to compare these outcomes in people with one of the following conditions:
gout
diabetes
gout and diabetes
observations take approximately 45 minutes and occur at a single time-point during 1 year
Intervention code [1] 290413 0
Not applicable
Comparator / control treatment
No comparators
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293343 0
Foot pain 100mm visual analogue scale
Timepoint [1] 293343 0
at baseline
Primary outcome [2] 293344 0
Foot disability - Manchester foot pain disability questionniare
Timepoint [2] 293344 0
at baseline
Primary outcome [3] 293345 0
walking velocity - 6 meter walk test
Timepoint [3] 293345 0
at baseline
Secondary outcome [1] 310822 0
Health Assessment questionnaire
Timepoint [1] 310822 0
at baseline
Secondary outcome [2] 310823 0
lower limb function - Lower limb task questionnaire
Timepoint [2] 310823 0
at baseline
Secondary outcome [3] 310824 0
global pain - 100mm visual analogue scale
Timepoint [3] 310824 0
at baseline
Secondary outcome [4] 310892 0
global well being - 100mm visual analogue scale
Timepoint [4] 310892 0
at baseline

Eligibility
Key inclusion criteria
people with a positive diagnosis of gout and/or diabetes
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current foot ulcer
Amputation
Current acute gout
Charcot foot
Unable walk 6 meters unaided
Acute infection
Co-existing inflammatory arthritis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2014
Actual
26/06/2014
Date of last participant enrolment
Anticipated
1/04/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6404 0
New Zealand
State/province [1] 6404 0
North Island

Funding & Sponsors
Funding source category [1] 290078 0
University
Name [1] 290078 0
Auckland University Technology
Country [1] 290078 0
New Zealand
Primary sponsor type
University
Name
Auckland University Technology
Address
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand
Country
New Zealand
Secondary sponsor category [1] 288773 0
Government body
Name [1] 288773 0
Counties Manukau DHB
Address [1] 288773 0
Counties Manukau Health District Health Board
19 Lambie Drive
Manukau
Auckland 2104
Country [1] 288773 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291784 0
Auckland University of Technology Ethics Committee (AUTEC)
Ethics committee address [1] 291784 0
WA505F Level 5 WA Building City Campus
Private Bag 92006 Auckland 1142
Ethics committee country [1] 291784 0
New Zealand
Date submitted for ethics approval [1] 291784 0
Approval date [1] 291784 0
01/06/2014
Ethics approval number [1] 291784 0
AUTEC 14/57

Summary
Brief summary
Gout is the most common form of inflammatory arthritis and has significant functional, social and financial impacts. The high and increasing hospital admission rates with gout, combined with the burden of co-morbidities such as diabetes, chronic kidney disease and cardiovascular disease are important current and future issues for the New Zealand health care system. We are proposing to identify the nature of foot problems experienced by patients attending community-based rheumatology outpatient clinics within CMDHB and to ascertain the availability of podiatric services for these patients. Patients with a history of gout and/or diabetes will be included into the study. We will measure demographic characteristics, foot and ankle characteristics that includes (i) measures of structure and function; ii) lifestyle and social factors; (iii) footwear suitability; (iv) tissue viability and skin and nail assessments; (v) baseline measures of foot impairment; (vi) the impact of any previous interventions, including surgery, footwear and foot orthoses. We have conducted a similar study in CMDHB in outpatient clinic based in a hospital setting. Our aim is to identify early detection of foot problems in patients to prevent the long term consequences of foot problems such as ulcerations, structural damage and deformity
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52022 0
Dr Simon Otter
Address 52022 0
Health and Research Rehabilitation Institute and School of Podiatry
AUT North Shore Campus
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand
Country 52022 0
New Zealand
Phone 52022 0
+64 (0)9 921-9999 extension 9006
Fax 52022 0
Email 52022 0
[email protected]
Contact person for public queries
Name 52023 0
Simon Otter
Address 52023 0
Health and Research Rehabilitation Institute and School of Podiatry
AUT North Shore Campus
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand
Country 52023 0
New Zealand
Phone 52023 0
+64 (0)9 921-9999 extension 9006
Fax 52023 0
Email 52023 0
[email protected]
Contact person for scientific queries
Name 52024 0
Simon Otter
Address 52024 0
Health and Research Rehabilitation Institute and School of Podiatry
AUT North Shore Campus
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand
Country 52024 0
New Zealand
Phone 52024 0
+64 (0)9 921-9999 extension 9006
Fax 52024 0
Email 52024 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.