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Trial registered on ANZCTR
Registration number
ACTRN12613000686707
Ethics application status
Approved
Date submitted
17/06/2013
Date registered
21/06/2013
Date last updated
21/06/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Is duct tape an effective alternative treatment to cryotherapy for verruca pedis?
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Scientific title
A randomised controlled trial evaluating the effectiveness of duct tape as an alternative treatment to cryotherapy for verruca pedis
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Secondary ID [1]
282683
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None
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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:
Verruca pedis
289389
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Condition category
Condition code
Skin
289718
289718
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0
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Dermatological conditions
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Alternative and Complementary Medicine
289719
289719
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants of the intervention will be required to wear a piece of duct tape over the verruca for up to 12 weeks, which is to be removed only for showering or bathing. Participants will be instructed to cut a piece of duct tape large enough to cover the entire surface of the wart. The wart would initially be debrided with a scalpel until pinpoint bleeding was visible. The piece of duct tape would then be placed over the affected area, and secured with fixomull.
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Intervention code [1]
287341
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Treatment: Other
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Intervention code [2]
287342
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Other interventions
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Comparator / control treatment
The standard treatment as a control is cryotherapy. Participants in the control group will be treated with liquid nitrogen cryotherapy every two weeks, as required over a 12-week period. The wart and surrounding skin would be disinfected with an alcohol wipe prior to the procedure. If the wart is particularly painful, or if the participant is likely to experience excessive discomfort from the procedure, local anaesthetic would be administered.
The wart would initially be debrided with a scalpel until pinpoint bleeding is visible. A cotton bud saturated with liquid nitrogen would be applied for five seconds, or until the area blanches. The frozen tissue would then be allowed to thaw for 30 seconds before the process is repeated once more. A cutiplast dressing would then be applied to the lesion.
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Control group
Active
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Outcomes
Primary outcome [1]
289811
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Resolution/regression of the verruca pedis. Such resolution and regression would be measured by comparing the original dimensions (length by width) of the verruca to the final dimensions of the verruca at the conclusion of 12 weeks following initial treatment.
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Assessment method [1]
289811
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Timepoint [1]
289811
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After 12 weeks.
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Secondary outcome [1]
303285
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Resolution/regression of the verruca pedis. Such resolution and regression would be measured by comparing the original dimensions (length by width) of the verruca with the dimensions of the verruca of the following fortnight. The verruca would be assessed either a total of six times (initial and five more follow up appointments) or until there is resolution of the verruca, within the twelve-week timeframe.
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Assessment method [1]
303285
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Timepoint [1]
303285
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Every fortnight.
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Eligibility
Key inclusion criteria
Clinically diagnosed verruca pedis upon initial presentation to the UWA Podiatry Clinic.
Minimal age of five years old.
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Minimum age
5
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?
Yes
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Key exclusion criteria
Known allergy to tapes or adhesives
Any condition that may impair wound healing (inclusive of peripheral vascular disease, diabetes, any condition requiring treatment with glucocorticoids, excessive smoking or alcohol consumption, and poor nutrition.
Cognitive impairment, intellectual disability or mental illness.
Previous verruca treatment with 3 months of recruitment.
Less than five years of age.
Pregnancy.
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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 is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each patient will be allocated a number, and to this number a treatment will be allocated randomly by allocating each treatment possibility (cryotherapy or duct tape) a random number, which is then organised in order of lowest to highest to determine which patient number will receive which treatment.
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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
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The computer program SPSS will be used to analysis our statistics.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
31/05/2013
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Actual
31/05/2013
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Date of last participant enrolment
Anticipated
15/07/2013
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment postcode(s) [1]
6973
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6009
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Funding & Sponsors
Funding source category [1]
287455
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University
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Name [1]
287455
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The University of Western Australia
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Address [1]
287455
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Podiatric Medicine Unit
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
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Country [1]
287455
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Australia
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Primary sponsor type
University
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Name
The University of Western Australia
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Address
Podiatric Medicine Unit
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
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Country
Australia
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Secondary sponsor category [1]
286199
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None
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Name [1]
286199
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Address [1]
286199
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Country [1]
286199
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289430
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The University of Western Australia's Human Research Ethics Committee
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Ethics committee address [1]
289430
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Human Research Ethics Office
The University of Western Australia (M459)
35 Stirling Highway
Crawley WA 6009
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Ethics committee country [1]
289430
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Australia
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Date submitted for ethics approval [1]
289430
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Approval date [1]
289430
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23/05/2013
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Ethics approval number [1]
289430
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RA/4/1/6079
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Summary
Brief summary
The study is to determine the efficacy of duct tape in treating verruca pedis compared to cryotherapy. Current literature consists of low-quality studies on the use of duct tape for treating verrucae revealing inconsistent results.
Thus, this study will assess the efficacy of duct tape in comparison to cryotherapy according to the criteria of total resolution, dimensions, resolution of surrounding warts, pain, adverse effects, participant satisfaction and cost effectiveness.
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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
40822
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A/Prof Reza N Naraghi
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Address
40822
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Podiatric Medicine
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
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Country
40822
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Australia
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Phone
40822
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+61 8 6488 4526
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Fax
40822
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Email
40822
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[email protected]
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Contact person for public queries
Name
40823
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A/Prof Reza N Naraghi
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Address
40823
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Podiatric Medicine
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
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Country
40823
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Australia
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Phone
40823
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+61 8 6488 4526
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Fax
40823
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Email
40823
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[email protected]
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Contact person for scientific queries
Name
40824
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A/Prof Reza N Naraghi
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Address
40824
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Podiatric Medicine
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
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Country
40824
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Australia
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Phone
40824
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+61 8 6488 4526
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Fax
40824
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Email
40824
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[email protected]
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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.
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