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Trial registered on ANZCTR


Trial ID
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?
Scientific title
A randomised controlled trial evaluating the effectiveness of duct tape as an alternative treatment to cryotherapy for verruca pedis
Secondary ID [1] 282683 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Verruca pedis 289389 0
Condition category
Condition code
Skin 289718 289718 0 0
Dermatological conditions
Alternative and Complementary Medicine 289719 289719 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287341 0
Treatment: Other
Intervention code [2] 287342 0
Other interventions
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.
Control group
Active

Outcomes
Primary outcome [1] 289811 0
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.
Timepoint [1] 289811 0
After 12 weeks.
Secondary outcome [1] 303285 0
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.
Timepoint [1] 303285 0
Every fortnight.

Eligibility
Key inclusion criteria
Clinically diagnosed verruca pedis upon initial presentation to the UWA Podiatry Clinic.
Minimal age of five years old.
Minimum age
5 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
Allocation is not concealed.
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.
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
The computer program SPSS will be used to analysis our statistics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 6973 0
6009

Funding & Sponsors
Funding source category [1] 287455 0
University
Name [1] 287455 0
The University of Western Australia
Address [1] 287455 0
Podiatric Medicine Unit
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
Country [1] 287455 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Podiatric Medicine Unit
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 286199 0
None
Name [1] 286199 0
Address [1] 286199 0
Country [1] 286199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289430 0
The University of Western Australia's Human Research Ethics Committee
Ethics committee address [1] 289430 0
Human Research Ethics Office
The University of Western Australia (M459)
35 Stirling Highway
Crawley WA 6009
Ethics committee country [1] 289430 0
Australia
Date submitted for ethics approval [1] 289430 0
Approval date [1] 289430 0
23/05/2013
Ethics approval number [1] 289430 0
RA/4/1/6079

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40822 0
A/Prof Reza N Naraghi
Address 40822 0
Podiatric Medicine
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
Country 40822 0
Australia
Phone 40822 0
+61 8 6488 4526
Fax 40822 0
Email 40822 0
reza.naraghi@uwa.edu.au
Contact person for public queries
Name 40823 0
A/Prof Reza N Naraghi
Address 40823 0
Podiatric Medicine
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
Country 40823 0
Australia
Phone 40823 0
+61 8 6488 4526
Fax 40823 0
Email 40823 0
reza.naraghi@uwa.edu.au
Contact person for scientific queries
Name 40824 0
A/Prof Reza N Naraghi
Address 40824 0
Podiatric Medicine
The University of Western Australia (M422)
35 Stirling Highway
Crawley WA 6009
Country 40824 0
Australia
Phone 40824 0
+61 8 6488 4526
Fax 40824 0
Email 40824 0
reza.naraghi@uwa.edu.au