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Trial registered on ANZCTR


Registration number
ACTRN12612000322831
Ethics application status
Approved
Date submitted
21/03/2012
Date registered
21/03/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of footwear in reducing foot pain in Australian veterans
Scientific title
Effectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans’ Affairs recipients not eligible for medical grade footwear: a randomised controlled trial
Secondary ID [1] 280092 0
DVA ARP1031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
foot pain 286007 0
Condition category
Condition code
Musculoskeletal 286193 286193 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 286194 286194 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low cost, off-the-shelf footwear (Dr Comfort [registered trademark], Vasyli Medical, Labrador, Queensland, Australia).

Men will receive the “Brian” style and women will receive the “Annie” style. Both styles feature a stretchable Lycra upper with Velcro closure and are available in three width fittings (medium, wide, extra-wide). These shoes have been selected as they are relatively low-cost compared to medical grade footwear (approximately AUD$250) and meet all commonly-used criteria for appropriate footwear (such as a low heel, appropriate fixation and adequate depth to accommodate toe deformities).

Participants will be asked to wear the shoes as often as possible/practical during the 16 week trial period.
Intervention code [1] 284419 0
Treatment: Devices
Comparator / control treatment
The "usual care" control group will continue to receive whatever podiatry treatment they would normally receive as a DVA client. This will typically include toenail maintenance and scalpel debridement of hyperkeratotic lesions (corns and calluses). Upon completion of the trial, they will be provided with the same footwear used in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 286667 0
Pain domain of the Foot Health Status Questionnaire.
Timepoint [1] 286667 0
Measured at baseline, 4, 8, 12 and 16 weeks. Analysis at 16 week time-point.
Secondary outcome [1] 296410 0
Function domain of the Foot Health Status Questionnaire.
Timepoint [1] 296410 0
Baseline and 16 weeks.
Secondary outcome [2] 296411 0
Manchester Foot Pain and Disability Index.
Timepoint [2] 296411 0
Baseline and 16 weeks.
Secondary outcome [3] 296412 0
Number of DVA podiatry treatments required.
Timepoint [3] 296412 0
Baseline to 16 week period.
Secondary outcome [4] 296413 0
Number of accidential falls reported.
Timepoint [4] 296413 0
Baseline to 16 week period.
Secondary outcome [5] 296414 0
Functional mobility (Timed Up and Go Test).
Timepoint [5] 296414 0
Baseline and 16 weeks.
Secondary outcome [6] 296415 0
Presence of hyperkeratotic lesions (corns and calluses), documented using clinical photographs.
Timepoint [6] 296415 0
Baseline and 16 weeks.
Secondary outcome [7] 296416 0
Number of participants using co-interventions to relieve foot pain (such as oral non-steroidal anti-inflammatory medications, topical medications and visits to other health-care practitioners).
Timepoint [7] 296416 0
Baseline to 16 week period.
Secondary outcome [8] 296417 0
Participant perception of overall treatment effect, assessed with the question: Overall, how has your foot pain changed since the start of the study, with a 5-point Likert scale response (marked worsening, moderate worsening, same, moderate improvement, or marked improvement).

For the purpose of analysis, this scale will then be dichotomised, where treatment success is defined as marked or moderate improvement on this scale.
Timepoint [8] 296417 0
16 weeks.
Secondary outcome [9] 296463 0
General health-related quality of life, assessed with the Short Form 12
Timepoint [9] 296463 0
Baseline and 16 weeks

Eligibility
Key inclusion criteria
To be included in the study, veterans will need to meet the following inclusion criteria:

(i) be a current DVA client not eligible for medical grade footwear;

(ii) have disabling foot pain, using the case definition of the Manchester Foot Pain and Disability Index;

(iii) have persistent foot pain, defined as foot pain present for at least 12 weeks, and;

(iv) be capable of understanding the English language in verbal and written form.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Veterans will not be eligible for inclusion in the study if they: (i) have diabetes and a history of foot ulceration (or current foot ulceration) or diabetic peripheral neuropathy (diagnosed with the 5.07 Semmes-Weinstein monofilament, using the International Working Group on the Diabetic Foot protocol); (ii) have a neurodegenerative disorder (e.g: Parkinson’s disease); (iii) have had a lower limb amputation or partial foot amputation (although single toe amputations will be permitted); (iv) have been prescribed contoured foot orthoses within the last 3 months (although simple flat insoles will be permitted, as will contoured foot orthoses prescribed more than 3 months ago), or; (v) have cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire)

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)
Participants will be randomly allocated to either a “usual care” control group or the intervention group. This will be undertaken using an interactive voice response telephone service provided by the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney, New South Wales, Australia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with random block sizes will be undertaken using an interactive voice response telephone service provided by the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney, New South Wales, Australia.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2012
Actual
6/11/2012
Date of last participant enrolment
Anticipated
Actual
31/05/2013
Date of last data collection
Anticipated
Actual
30/10/2013
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284851 0
Government body
Name [1] 284851 0
Australian Department of Veterans' Affairs
Country [1] 284851 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora, Victoria 3086
Country
Australia
Secondary sponsor category [1] 283729 0
Government body
Name [1] 283729 0
Australian Department of Veterans' Affairs
Address [1] 283729 0
300 Latrobe Street, Melbourne Victoria 3000
Country [1] 283729 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286840 0
Australian Department of Veterans' Affairs
Ethics committee address [1] 286840 0
Department of Veterans' Affairs
PO Box 21
Woden ACT 2606
Ethics committee country [1] 286840 0
Australia
Date submitted for ethics approval [1] 286840 0
28/03/2012
Approval date [1] 286840 0
18/06/2012
Ethics approval number [1] 286840 0
EC00366

Summary
Brief summary
Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans’ Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, the purpose of this randomised controlled trial is to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear.

One hundred and twenty DVA clients with foot pain residing in the northern suburbs of Melbourne, Australia, who are not eligible for medical grade footwear will be recruited from the DVA database, and will be randomly allocated to an intervention group or a “usual care” control group. The intervention group will continue to receive their usual DVA-subsidised podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort [registered trademark]) fitted by a podiatrist. The control group will also continue to receive DVA-subsidised podiatry care, but will not be provided with the footwear until the completion of the study. The primary outcome measure will be pain subscale on the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8, 12 and 16 weeks. Secondary outcome measures measured at baseline and 16 weeks will include the function subscale of the FHSQ, the Manchester Foot Pain and Disability Index, the number of DVA podiatry treatments required during the study period, general health-related quality of life (using the Short Form 12), the number of falls experienced during the follow-up period, the Timed Up and Go Test, the presence of hyperkeratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain, and participants’ perception of overall treatment effect.
Trial website
www.veteransfootwearstudy.com
Trial related presentations / publications
1: Menz HB, Auhl M, Ristevski S, Frescos N, Munteanu SE. Evaluation of the
accuracy of shoe fitting in older people using three-dimensional foot scanning. J
Foot Ankle Res. 2014 Jan 23;7(1):3. doi: 10.1186/1757-1146-7-3. PubMed PMID:
24456656; PubMed Central PMCID: PMC3903039.

2: Menz HB, Auhl M, Ristevski S, Frescos N, Munteanu SE. Effectiveness of
off-the-shelf, extra-depth footwear in reducing foot pain in older people: a
randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2015 Apr;70(4):511-7.
doi: 10.1093/gerona/glu169. Epub 2014 Sep 9. PubMed PMID: 25205761.


3: Menz HB, Auhl M, Ristevski S, Frescos N, Munteanu SE. Comparison of the
responsiveness of the foot health status questionnaire and the Manchester foot
pain and disability index in older people. Health Qual Life Outcomes. 2014 Oct
25;12:158. doi: 10.1186/s12955-014-0158-4. PubMed PMID: 25344024; PubMed Central
PMCID: PMC4213529.
Public notes

Contacts
Principal investigator
Name 33882 0
Prof Hylton Menz
Address 33882 0
Faculty of Health Sciences, La Trobe University Bundoora, Victoria 3086
Country 33882 0
Australia
Phone 33882 0
+61-3-94795801
Fax 33882 0
+61-3-94795415
Email 33882 0
h.menz@latrobe.edu.au
Contact person for public queries
Name 17129 0
Prof Prof Hylton Menz
Address 17129 0
Faculty of Health Sciences, La Trobe University
Bundoora, Victoria 3086
Country 17129 0
Australia
Phone 17129 0
+61-3-94795801
Fax 17129 0
+61-3-94795415
Email 17129 0
h.menz@latrobe.edu.au
Contact person for scientific queries
Name 8057 0
Prof Prof Hylton Menz
Address 8057 0
Faculty of Health Sciences, La Trobe University
Bundoora, Victoria 3086
Country 8057 0
Australia
Phone 8057 0
+61-3-94795801
Fax 8057 0
+61-3-94795415
Email 8057 0
h.menz@latrobe.edu.au

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
SourceTitleYear of PublicationDOI
Dimensions AIEffectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans’ Affairs recipients not eligible for medical grade footwear: study protocol for a randomized controlled trial2013https://doi.org/10.1186/1745-6215-14-106
N.B. These documents automatically identified may not have been verified by the study sponsor.