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Trial registered on ANZCTR


Registration number
ACTRN12611000224921
Ethics application status
Approved
Date submitted
28/02/2011
Date registered
1/03/2011
Date last updated
26/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying the relationship between biochemical markers and wound healing in chronic venous leg ulcers treated with compression therapy
Scientific title
Identifying relationships between compression type, biochemical markers and wound healing outcomes in patients with venous leg ulcers: Randomised controlled trial.
Secondary ID [1] 259689 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
venous leg ulcers - Compression thereapy is the gold standard treatment for venous leg ulcers, however, the biological mechanisims underlying the healing process and differences between different types of treatment are poorly understood. This study will identify relationships between two different types of compression systems to treat venous leg ulcers, biochemical markers (identified from samples of wound exudate) and progress in wound healing in patients with venous leg ulcers. 261259 0
Condition category
Condition code
Cardiovascular 259413 259413 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Four layer compression bandage system - Profore, applied once per week for the 24 weeks of the study (or until healed, whichever occurs sooner), as per producer's instructions and patient's ankle circumference e.g.
Less than 18cm: 2 or more Orthopaedic wool, 1 crepe, 1 Class 3a bandage, 1 Cohesive bandage;
18-25cm: 1 Orthopaedic wool, 1 Crepe, 1 Class 3a bandage, 1 Cohesive bandage;
25-30cm: 1 Orthopaedic wool, 1 Class 3c, 1 Cohesive bandage;
Greater than 30cm: 1 Orthopaedic wool, 1 Class 3a, 1 Class 3c, 1 Cohesive.
Intervention code [1] 258116 0
Treatment: Other
Comparator / control treatment
Group 2: Class 3 (In Australia, Class 3 compression hosiery provides 30-35mmHg pressure at the ankle level) compression hosiery system; applied and checked once per week at the wound clinic (patient has the option of removing hosiery at night and replacing first thing in the morning); padding is applied as necessary, a holding bandage or sleeve and then Class 3 compression hosiery applied.
Control group
Active

Outcomes
Primary outcome [1] 262217 0
Number of healed ulcers / group: Ulcer area will be calculated by using wound tracings, digital photography and using Visitrak to determine area reduction, percent reduction and total healing rates. A healed ulcer is defined as full epithelialisation maintained for at least two weeks.
Timepoint [1] 262217 0
24 weeks from randomisation
Primary outcome [2] 262218 0
Biochemical markers associated with healing:
Wound fluid samples will be gathered for laboratory analysis on admission, then every two weeks until 24 weeks (or until ulcer has healed if this is earlier). This involves applying an occlusive wound dressing (Opsite) over the wound and after one hour the exudate under the dressing is recovered by flushing in 1 ml sterile, isotonic saline. The samples will then be centrifuged at 14000g for 10 minutes to remove particulate debris, filter sterilised (0.22 micrometres) and stored at -80 degrees C until analysis. Protein concentration of the filtered wound fluid sample will be determined using BCA Assay38, and 2 mg (for 2-D electrophoresis) or 4 mg (for ProteomeLab) of protein will be loaded on a Agilent Multi Affinity Removal System (MARS) column to remove 6 abundant proteins (albumin, haptoglobin, alpha-1-antitripsin, transferrin, IgA and IgG) in order to increase the sensitivity and resolution of the analysis. 2-D gel electrophoresis of the wound fluid will be performed using 11cm Zoom gels (Invitrogen), followed by silver-staining, imaging and analysis using BioRad image analysis software. Stained proteins of interest with a differential density of greater than 2 fold will be excised and identified using MALDI-TOF-TOF and LC-MS-MS. Select samples of wound fluid containing candidate proteins of interest will be further analysed using a ProteomeLab PF 2D Protein Fractionation System. Further characterisation of specific proteins will be carried out using either classical proteomic techniques (protein digestion and mass fingerprinting) or the ProteomeLab PA 800 system (capillary electrophoresis). Having identified "candidate" proteins that are differentially expressed in wound fluid in response to the pressure therapy, further characterisation studies using techniques such as antibody-based immunological studies, biochemical studies and PCR will be pursued as a second approach to validate the changes in protein expression.
Timepoint [2] 262218 0
Every 2 weeks for 24 weeks from randomisation
Primary outcome [3] 262219 0
Time to ulcer healing: Ulcer area will be calculated by using wound tracings, digital photography and using Visitrak to determine area reduction, percent reduction and total healing rates. A healed ulcer is defined as full epithelialisation maintained for at least two weeks.
Timepoint [3] 262219 0
Assessed every week up to 24 weeks from randomisation
Secondary outcome [1] 273347 0
Pain - measured with the Medical Outcomes Study Pain Measures
Timepoint [1] 273347 0
Measured at baseline, then 12 and 24 weeks from baseline
Secondary outcome [2] 273348 0
Quality of life: Spitzer's Quality of Life scale
Timepoint [2] 273348 0
Measures at baseline, then 12 and 24 weeks from baseline

Eligibility
Key inclusion criteria
- Clients with leg ulcers of venous aetiology
- Ankle Brachial Pressure Index >0.8 and <1.3
- Ulcer size between 1cm2 – 30cm2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clients unable to mobilise at all i.e. completely bed or wheelchair bound
- Ankle Brachial Pressure Index <0.8 or >1.3
- Presence of clinical signs of infection on admission
- Clients with cognitive impairment

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)
All patients presenting with a venous leg ulcer and fitting the inclusion and exclusion criteria will be invited to participate in the study. Once a patient has been identified by the clinician in charge as fitting the inclusion criteria, the Research Assistant will approach the patient to invite them to participate and give them an information and consent package. If the patient consents to participate in the study, the Research Assistant will collect baseline data from the patient’s records and give the patient a questionnaire to fill in. The Research Assistant will open a randomisation envelope and the patient will be allocated to either Treatment group A or Treatment group B. A staff member not working on this project will have previously filled sealed opaque envelopes with the allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to commencement of the study a randomisation allocation sequence will be generated with a computerised randomisation program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2006
Actual
15/09/2006
Date of last participant enrolment
Anticipated
Actual
20/01/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3657 0
4059
Recruitment postcode(s) [2] 3658 0
4120
Recruitment postcode(s) [3] 3659 0
4102
Recruitment postcode(s) [4] 3675 0
4006

Funding & Sponsors
Funding source category [1] 258575 0
Government body
Name [1] 258575 0
National Health and Medical Research Council
Country [1] 258575 0
Australia
Primary sponsor type
University
Name
Prof. Helen Edwards
Address
School of Nursing
Queensland University of Technology
Victoria Park Rd
Kelvin Grove, Qld, 4059
Country
Australia
Secondary sponsor category [1] 257713 0
Hospital
Name [1] 257713 0
Princess Alexandra Hospital
Address [1] 257713 0
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba, Qld, 4102
Country [1] 257713 0
Australia
Secondary sponsor category [2] 257714 0
Hospital
Name [2] 257714 0
Royal Brisbane & Women's Hospital
Address [2] 257714 0
Royal Brisbane & Women's Hospital
Herston Rd,
Herston, Qld, 4006
Country [2] 257714 0
Australia
Secondary sponsor category [3] 257715 0
Other Collaborative groups
Name [3] 257715 0
Spiritus Community Nursing Services
Address [3] 257715 0
138 Juliette Street
Greenslopes QLD 4120
Country [3] 257715 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260557 0
Queensland Unviversity HREC
Ethics committee address [1] 260557 0
Ethics committee country [1] 260557 0
Australia
Date submitted for ethics approval [1] 260557 0
Approval date [1] 260557 0
05/12/2005
Ethics approval number [1] 260557 0
3817H
Ethics committee name [2] 260558 0
Princess Alexandra Hospital HREC
Ethics committee address [2] 260558 0
Ethics committee country [2] 260558 0
Australia
Date submitted for ethics approval [2] 260558 0
Approval date [2] 260558 0
02/08/2006
Ethics approval number [2] 260558 0
2004/086
Ethics committee name [3] 260559 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [3] 260559 0
Ethics committee country [3] 260559 0
Australia
Date submitted for ethics approval [3] 260559 0
Approval date [3] 260559 0
30/06/2006
Ethics approval number [3] 260559 0
2006045
Ethics committee name [4] 260560 0
Spiritus HREC
Ethics committee address [4] 260560 0
Ethics committee country [4] 260560 0
Australia
Date submitted for ethics approval [4] 260560 0
Approval date [4] 260560 0
12/12/2006
Ethics approval number [4] 260560 0
n/a

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

Contacts
Principal investigator
Name 32277 0
Prof Helen Edwards
Address 32277 0
Faculty of Health, Queensland University of Technology
Victoria Park Road
Kelvin Grove, Qld, 4059
Country 32277 0
Australia
Phone 32277 0
+61 7 31384523
Fax 32277 0
Email 32277 0
h.edwards@qut.edu.au
Contact person for public queries
Name 15524 0
Professor Helen Edwards
Address 15524 0
Faculty of Health, Queensland University of Technology Victoria Park Rd Kelvin Grove, Qld, 4059
Country 15524 0
Australia
Phone 15524 0
+61 7 31384523
Fax 15524 0
+61 7 31385895
Email 15524 0
h.edwards@qut.edu.au
Contact person for scientific queries
Name 6452 0
Professor Helen Edwards
Address 6452 0
School of Nursing and Midwifery
Queensland University of Technology
Victoria Park Rd
Kelvin Grove, Qld, 4059
Country 6452 0
Australia
Phone 6452 0
+61 7 31384523
Fax 6452 0
+61 7 31385895
Email 6452 0
h.edwards@qut.edu.au

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.