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Trial registered on ANZCTR


Registration number
ACTRN12608000599370
Ethics application status
Approved
Date submitted
15/09/2008
Date registered
1/12/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a short stretch compression bandaging system in the management of people with venous ulceration.
Scientific title
A pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a short stretch compression bandaging system in the management of people with venous ulceration.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic venous insufficency 3689 0
venous leg ulceration 3690 0
Condition category
Condition code
Cardiovascular 3855 3855 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
graduated three layer straight tubular bandaging system which consists of an elastic tubular bandage that is often used as a support bandage.
In this study the investigational product will be used in graduated lengths of 3 layers of the tubular bandage system as follows:
1. from base of toes to just under knee (long layer)
2. from base of toes to above calf pump (medium layer)
3. from base of toes to mid gaiter (short layer)
participants will be bandaged weekly for 12 weeks and will keep this bandage on between treatment visits.
Intervention code [1] 3403 0
Treatment: Devices
Comparator / control treatment
Standard short stretch compression bandaging system consists of:
1. A padding layer
2. 10cm inelastic short stretch compression bandage
3. A tubular stocking.
All layers of standard compression therapy will be applied from base of toes to just under the knee. Participants will be bandaged weekly for 12 weeks and will keep this bandage on between treatment visits.
Control group
Active

Outcomes
Primary outcome [1] 4757 0
To assess rate of percentage reduction of wound size from baseline compared to week 12 following randomisation. Wound size will be measured with planimetry wound measurement system Visitrak wound tracing: The ulcer outline will be traced and the ulcer area calculated to determine ulcer size
Timepoint [1] 4757 0
The outcome will be assessed at baseline and end of treatment period at 12 weeks following randomisation
Secondary outcome [1] 8035 0
To assess the proportion of ulcers healed within the trial period. Complete healing is defined as full 100% epithelialisation or skin closure without drainage based on clinical assessment and digital photo.
Timepoint [1] 8035 0
end of treatment period at 12 weeks following randomisation
Secondary outcome [2] 8036 0
Quality of Life will be measured with SF 36 and Cardiff Wound Impact Schedue
Timepoint [2] 8036 0
baseline, end of 12 week treatment and at 3 month follow up
Secondary outcome [3] 8037 0
Incidence of treatment related adverse events. Examples of an adverse event include:
1. Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition.
2. New conditions detected or diagnosed after graduated three layer straight tubular bandaging system administration even though it may have been present prior to the start of the study.
Timepoint [3] 8037 0
end of treatment period at 12 weeks following randomisation and at 3 months follow up
Secondary outcome [4] 8038 0
Incidence of Serious Adverse Event: A serious adverse event is any untoward medical occurrence that at any dose:
1. Results in death
2. Is life threatening (i.e. the study participant is at immediate risk of death at the time the event occurred; it does not refer to an event which might have caused death had it been more severe)
3. Requires hospitalization or prolongation of existing hospitalization
4. Results in persistent or significant disability/incapacity
and serious adverse events. Serious adverse events will be assessed by site invetigator
Timepoint [4] 8038 0
end of treatment period at 12 weeks following randomisation and at 3 months follow up

Eligibility
Key inclusion criteria
Male and female study participants who meet all of the following criteria can be entered into the study:
1. Presence of a venous ulcer that is confirmed by Clinical signs, Etiologic classification, Anatomical distribution and Pathological dysfunction (CEAP) assessment to be the result of chronic venous insufficiency.
2. Aged over 18 years.
3. Present with clinical evidence of chronic venous insufficiency and chronic venous ulceration as evidenced by one or more of the following:
i. lower limb pigmentation,
ii. varicose eczema,
iii. lipodermatosclerosis,
iv. varicose veins.
4. Chronic venous leg ulcer (target ulcer) that
i. Has been present for at least 4 weeks
ii. is of an area equal to or greater than 1 cm2 but less than or equal to 20 cm2 as measured by digital planimetry techniques,
5. Ankle Brachial Pressure index of equal or greater than 0.8 mmHg.
6. Ankle circumference of greater than 18 cm and less than 25 cm
7. Mobile, and able to return for required treatments and study evaluations without undue hardship.
8. Able to give Informed Consent.
9. Able to understand and comply with the requirements of the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study participants who meet any of the following criteria will not be eligible for participation in this study:
1. Unable or unwilling to wear compression bandage as directed.
2. Allergy to any of the trial products used.
3. Immobility.
4. Participation in any other clinical trial or exposure to an investigational drug within 30 days of study enrolment.
5. Evidence of severe liver disease, cardiac disease or chronic pulmonary disease.
6. Medical condition likely to require systemic corticosteroids during the study period.
7. Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness).
8. Clinically documented thrombo-phlebitis or suspected deep vein thrombosis.
9. Unable or unwilling to attend clinic for weekly treatment
10. Participation in this trial previously and/or who dropped out or were withdrawn.

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)
Patients will be randomised to receive either control or intervention group using a central computer generated random number generated by using a central computer generated randomisation sequence.
The randomization code will be sent to the Investigator (or designee) who will prepare treatments according to the randomisation code.

To decrease bias and confounders the decision to accept or reject a participant will be made using inclusion and exclusion criteria. Informed consent will be obtained by participant without knowing the next assignment in the sequence. Independent clinicians will apply compression bandage systems according to the computer generated list allocation. The code will be revealed to the researchers once the recruitment, data collection and wound measurement analysis are completed. The allocation list will be stored within the Clinical Informatics and Data Management Centre of the Department of Epidemiology and Preventative Medicine (DEPM).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratefied by study site and wound size. Patients will be randomised to receive either control or intervention group using a central computer generated randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1155 0
3084
Recruitment postcode(s) [2] 1221 0
3004

Funding & Sponsors
Funding source category [1] 3869 0
University
Name [1] 3869 0
Monash University
Country [1] 3869 0
Australia
Primary sponsor type
University
Name
Monash University
Address
DEPM, Monash University
level 3 Bunett Building
The Alfred, Commercial Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 3473 0
None
Name [1] 3473 0
Address [1] 3473 0
Country [1] 3473 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6144 0
Research and Ethics Unit Alfred Hospital
Ethics committee address [1] 6144 0
Commercial Road
Melbourne VICTORIA 3004
Ethics committee country [1] 6144 0
Australia
Date submitted for ethics approval [1] 6144 0
24/10/2008
Approval date [1] 6144 0
Ethics approval number [1] 6144 0
Ethics committee name [2] 6146 0
Austin Ethics
Ethics committee address [2] 6146 0
Studley Park road Heidelberg
VICTORIA 3084
Ethics committee country [2] 6146 0
Australia
Date submitted for ethics approval [2] 6146 0
14/10/2008
Approval date [2] 6146 0
Ethics approval number [2] 6146 0

Summary
Brief summary
Venous disease is the most common cause of leg ulcers. The refractory nature of venous ulcers affects the quality of life and work productivity of those persons afflicted. This, in combination with the high costs of long-term therapy, makes venous ulcers a major health problem in developed countries. Management of venous leg ulcers is based on understanding pathophysiologic abnormalities. In recent years, identifying prognostic factors for healing and developing novel therapeutic approaches for venous ulcers have offered valuable tools for the management of patients with this disorder.

Compression increases ulcer healing rates compared with no compression. Multi-layered systems are more effective than single-layered systems. High compression is more effective than low compression but there are no clear differences in the effectiveness of different types of high compression(1).
The aim of this study is to evaluate the efficacy and safety of graduated three layer straight tubular bandaging when compared to 4 layer compression bandaging in healing venous ulcers in patients with chronic venous ulceration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28932 0
Address 28932 0
Country 28932 0
Phone 28932 0
Fax 28932 0
Email 28932 0
Contact person for public queries
Name 12089 0
Carolina Weller
Address 12089 0
DEPM, Monash University
The Alfred, Commercial Road
Melbourne Vic 3004
Country 12089 0
Australia
Phone 12089 0
+61 3 99030623
Fax 12089 0
Email 12089 0
[email protected]
Contact person for scientific queries
Name 3017 0
Professor John McNeil
Address 3017 0
DEPM, Monash University
The Alfred, Commercial Road
Melbourne Vic 3004
Country 3017 0
Australia
Phone 3017 0
+61 3 99030565
Fax 3017 0
Email 3017 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4231Study results articleYes Wound Rep Reg (2012) © 2012 by the Wound Healing ... [More Details]

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