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Trial registered on ANZCTR


Registration number
ACTRN12605000565640
Ethics application status
Approved
Date submitted
20/09/2005
Date registered
30/09/2005
Date last updated
7/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Blister Prevention Study
Scientific title
Random Controlled Trial of Sock and Lacing Systems to Prevent Blisters in Australian Soldiers
Secondary ID [1] 286665 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blisters 691 0
Condition category
Condition code
Skin 766 766 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is testing the efficacy of two blister prevention strategies on the Australian Army recruit population. The first strategy is the use of a two-sock system using polyester and polypropelene socks. Recruits will be randomly assigned to one of four groups. Group 1 will be given a polyester liner sock with the current army standard sock, Group 2 will be given the polyester liner with the polypropelene sock, Group 3 the polyproplene sock alone. The second intervention is tying off the army boots at the ankle height before continuing the lacing further up the boot. Half the subjects in each group will be randomly selected to tie the laces below the ankle and the other half will lace as usual. The study will continue until approximately 600 recruits have been recruited for the study.
Intervention code [1] 653 0
None
Intervention code [2] 291815 0
Prevention
Comparator / control treatment
Group 4 will be the control group and be given the current standard army sock alone
Control group
Active

Outcomes
Primary outcome [1] 969 0
Evaluate the presence of blisters.
Timepoint [1] 969 0
Measured within 24 hours of a route march and at foot inspection times evenly spaced throughout training. The results of these will be compared between the four sock groups and two lacing systems to identify the combinations that best prevent blisters and minor skin irritations.
Primary outcome [2] 970 0
Evaluate blister severity.
Timepoint [2] 970 0
Measured within 24 hours of a route march and at foot inspection times evenly spaced throughout training. The results of these will be compared between the four sock groups and two lacing systems to identify the combinations that best prevent blisters and minor skin irritations.
Primary outcome [3] 971 0
Evaluate other minor skin irritations
Timepoint [3] 971 0
Measured within 24 hours of a route march and at foot inspection times evenly spaced throughout training. The results of these will be compared between the four sock groups and two lacing systems to identify the combinations that best prevent blisters and minor skin irritations.
Secondary outcome [1] 1843 0
The relationship between the blister rates and skin irritations and ambient temperature, humidity and subject body weight.
Timepoint [1] 1843 0
The temperature and humidity readings will be taken hourly during training time using a Wet Bulb Globe Temperature apparatus.
Secondary outcome [2] 1844 0
The relationship between blister formation and the likelihood of injury.
Timepoint [2] 1844 0
The temperature and humidity readings will be taken hourly during training time using a Wet Bulb Globe Temperature apparatus.
Secondary outcome [3] 1845 0
Body weight and sex will be recorded at the commencement of training.
Timepoint [3] 1845 0
Commencement of training

Eligibility
Key inclusion criteria
All recruits that march into the Army Recruit Training Centre will be included in the study.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered envelopes prepared by independent party
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
odd/even Random number generation by NHMRC Clinical Trials Centre
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
NSW
Recruitment postcode(s) [1] 9653 0
2661 - Kapooka

Funding & Sponsors
Funding source category [1] 846 0
Government body
Name [1] 846 0
Department of Defence
Address [1] 846 0
Kapooka Health centre
Blamey Barracks
Kapooka NSW 2661
Country [1] 846 0
Australia
Primary sponsor type
Government body
Name
Department of Defence
Address
Kapooka Health Centre
Blamey Barracks
Kapooka NSW 2661
Country
Australia
Secondary sponsor category [1] 713 0
Individual
Name [1] 713 0
Mark Barclay
Address [1] 713 0
Physiotherapy Dept
Kapooka Health centre
Blamey Barracks
Kapooka NSW 2661
Country [1] 713 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2110 0
Australian Defence Research Comittee
Ethics committee address [1] 2110 0
Executive Secetary
Australian Defence Research Comittee
CP 2-7-66
Dept of Defence
Canberra ACT
2600
Ethics committee country [1] 2110 0
Australia
Date submitted for ethics approval [1] 2110 0
30/09/2003
Approval date [1] 2110 0
04/11/2003
Ethics approval number [1] 2110 0
340/03

Summary
Brief summary
RCT of sock system and lacing modifications to prevent blisters in soldiers
Trial website
Trial related presentations / publications
No trial related presentations/publications as yet
Public notes

Contacts
Principal investigator
Name 35689 0
Mr Mark Barclay
Address 35689 0
Kapooka Health Centre
Physio Dept
Blamey Barracks
Kapooka NSW 2661
Country 35689 0
Australia
Phone 35689 0
+61 02 69338450
Fax 35689 0
+61 02 69338529
Email 35689 0
mark.barclay@defence.gov.au
Contact person for public queries
Name 9842 0
Mr Mark Barclay
Address 9842 0
Physiotherapy Department
Kapooka Health Centre
Army Recruit Training Centre
Kapooka NSW 2661
Country 9842 0
Australia
Phone 9842 0
+61 2 69338450
Fax 9842 0
Email 9842 0
mark.barclay@defence.gov.au
Contact person for scientific queries
Name 770 0
Mr Mark Barclay
Address 770 0
Physiotherapy Department
Kapooka Health Centre
Army Recruit Training Centre
Kapooka NSW 2661
Country 770 0
Australia
Phone 770 0
+61 2 69338450
Fax 770 0
Email 770 0
mark.barclay@defence.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary