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Trial registered on ANZCTR


Registration number
ACTRN12611000623998
Ethics application status
Approved
Date submitted
3/06/2011
Date registered
20/06/2011
Date last updated
20/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Thermal Imaging of Stress Injuries in The Lower Limbs
Scientific title
Objective clinical assessment of the efficacy of longwave infrared interrogation of osseous stress pathophysiology in the anteromedial pretibial tissues of Australian Army basic trainees
Secondary ID [1] 262312 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osseous stress pathology 268019 0
Condition category
Condition code
Musculoskeletal 268149 268149 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Passive, non-invasive, non-contact, thermal infrared thermometry of anteromedial aspect of lower leg. supervised by a member of the investigation team; one image acquired per participant, every 4 weeks, for 12 weeks. 1 image acquired on day 0, thus 4 images in total per participant.
Intervention code [1] 266704 0
Not applicable
Intervention code [2] 266718 0
Early detection / Screening
Intervention code [3] 266719 0
Treatment: Drugs
Comparator / control treatment
None- Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266898 0
correlation of longwave infrared imaging aberration to MRI aberration
Timepoint [1] 266898 0
1 to less than 6 months after image acquisition
Secondary outcome [1] 276581 0
Correlation of longwave infrared imaging aberration to nuclear scintigraphic aberration
Timepoint [1] 276581 0
6 months after image acquisition

Eligibility
Key inclusion criteria
Fit for Australian Regular Army basic training
Minimum age
17 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindicative medical history, e.g. previous lower-limb fracture, superficial varicosity within region of interest, dermal abnormality

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
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)

Funding & Sponsors
Funding source category [1] 267188 0
University
Name [1] 267188 0
Curtin University
Address [1] 267188 0
GPO Box U1987 Perth, Western Australia 6845
Country [1] 267188 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987 Perth, Western Australia 6845
Country
Australia
Secondary sponsor category [1] 266262 0
None
Name [1] 266262 0
Address [1] 266262 0
Country [1] 266262 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269182 0
ADHREC
Ethics committee address [1] 269182 0
CP2-7-100
Campbell Park Offices
Campbell ACT 2600
Ethics committee country [1] 269182 0
Australia
Date submitted for ethics approval [1] 269182 0
Approval date [1] 269182 0
13/09/2010
Ethics approval number [1] 269182 0
1/10/0592

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32698 0
Address 32698 0
Country 32698 0
Phone 32698 0
Fax 32698 0
Email 32698 0
Contact person for public queries
Name 15945 0
Dr Masood Mehmood Khan
Address 15945 0
Department of Mechanical Engineering,
Curtin University,
GPO Box U1987 Perth,
Western Australia 6845
Country 15945 0
Australia
Phone 15945 0
61-8-92669205
Fax 15945 0
61-8-92662681
Email 15945 0
Masood.Khan@curtin.edu.au
Contact person for scientific queries
Name 6873 0
Dr Masood Mehmood Khan
Address 6873 0
Department of Mechanical Engineering,
Curtin University,
GPO Box U1987 Perth,
Western Australia 6845
Country 6873 0
Australia
Phone 6873 0
61-8-92669205
Fax 6873 0
61-8-92662681
Email 6873 0
Masood.Khan@curtin.edu.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