Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000425594
Ethics application status
Approved
Date submitted
30/09/2006
Date registered
3/10/2006
Date last updated
19/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement of tissue oxygen to assess healing potential of chronic wounds.
Scientific title
Measurement of tissue oxygen to assess healing potential of chronic wounds.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
They are to be located in the lower limb 1397 0
Condition category
Condition code
Skin 1489 1489 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessment of oxygen tension of skin adjacent to wound using TCM400 (Radiometer Pacific, Copenhagen Denmark). This will be measured upon initial contact, then re-measured 4 weeks later. At the same time, wound size will also be measured and healing rate will be calculated.
Intervention code [1] 1383 0
Early detection / Screening
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2060 0
Oxygen tension
Timepoint [1] 2060 0
Measured at initial contact and then four weeks later.
Secondary outcome [1] 3549 0
Healing rates
Timepoint [1] 3549 0
Over four weeks

Eligibility
Key inclusion criteria
With wounds that attend the Chronic wound service.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Wounds that are infected, Stage 3 and 4 pressure ulcers.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1626 0
Charities/Societies/Foundations
Name [1] 1626 0
Rebecca L. Cooper Medical Research Foundation
Country [1] 1626 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Aged Residential Care Services,
Austin Health
Heidelberg Repatriation Campus
PO Box 5444,
Heidelberg West, 3081.
Country
Australia
Secondary sponsor category [1] 1427 0
None
Name [1] 1427 0
N/A
Address [1] 1427 0
Country [1] 1427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3073 0
Austin Health Human Research Ethics committee
Ethics committee address [1] 3073 0
Austin Health Human Research Ethics committee
Austin Health
PO Box 5555
Heidelberg 3086
Ethics committee country [1] 3073 0
Australia
Date submitted for ethics approval [1] 3073 0
Approval date [1] 3073 0
Ethics approval number [1] 3073 0

Summary
Brief summary
The study aims to measure skin oxygen tension of skin adjacent to chronic wounds and assess whether low oxygen tension occurs in wounds that have delayed healing. If there is a relationship, this measurement device may be used as a screening tool to identify those people who require additional therapies in order to improve healing rates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27610 0
Address 27610 0
Country 27610 0
Phone 27610 0
Fax 27610 0
Email 27610 0
Contact person for public queries
Name 10572 0
Mr Geoff Sussman
Address 10572 0
Victorian College of Pharmacy
Monash University
381 Royal Parade
Parkville VIC 3052
Country 10572 0
Australia
Phone 10572 0
+61 3 99039619
Fax 10572 0
Email 10572 0
[email protected]
Contact person for scientific queries
Name 1500 0
Associate Professor Michael Woodward
Address 1500 0
Aged Care Services
Heidelberg Repatriation Hospital
PO Box 5444
Heidelberg West VIC 3081
Country 1500 0
Australia
Phone 1500 0
+61 3 94962185
Fax 1500 0
Email 1500 0
[email protected]

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.