Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000416291
Ethics application status
Approved
Date submitted
27/02/2009
Date registered
5/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Forever Healed:
Breaking the cycle of wound recurrence among persons with chronic leg ulceration
Scientific title
A randomised controlled trial to assess the effects of two different compression stockings on breaking the cycle of wound recurrence among persons with chronic leg ulceration.
Secondary ID [1] 253569 0
What is a secondary id?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous leg ulcer recurrence 4383 0
Condition category
Condition code
Other 4630 4630 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Physical Medicine / Rehabilitation 237087 237087 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study considers people who have venous disease and history of leg ulceration. Once the venous leg ulcer is assessed as healed (100% epithelialised), clients will be invited to participate in a Randomised Controlled Trial comparing two types of commonly prescribed medical grade below knee maintenance compression stockings. The stocking most closely resembling the treatment intervention is a Venosan Class 2 stocking which offers 23 - 32 mmHg compression at the ankle. The monitoring period includes 2 weeks wearing compression bandaging and following this, 24 weeks wearing the stocking to which the participant has been randomised. Clients will ideally manage their stocking application and removal independently however formal or informal supports may be engaged if needed. Clients are requested to wear their stockings from first thing in the morning until retiring to bed in the evening. Participants will be reviewed at 13 and 26 weeks from the date their venous ulcer healed.
Intervention code [1] 4115 0
Prevention
Comparator / control treatment
The stocking most closely resembling the control intervention is a Venosan Class 3 stocking which offers 34 - 46 mmHg compresion at the ankle. The only difference between this stocking and the other treatment is the level of compression provided which is higher for this treatment.
Control group
Active

Outcomes
Primary outcome [1] 5500 0
Time to venous leg ulcer recurrence. Visual inspection of the study leg will be undertaken and a digital image taken by a registered nurse attending an inperson data collection visit.
Timepoint [1] 5500 0
The first data collection will occur at 13 weeks following venous leg ulcer healing. The second data collection will occur at 26 weeks from the date the venous leg ulcer healed (therefore another 13 weeks later).
Secondary outcome [1] 9262 0
Cost of care. This includes the cost of the compression stockings, stocking applicators and nursing time for any care provided or data collection attended during the 26 week monitoring period.
Timepoint [1] 9262 0
This is a one off measure at the end of the monitoring period (26 weeks post venous leg ulcer healing).
Secondary outcome [2] 9276 0
Participant satisfaction. This involves a satisfaction survey administeded to all participants.
Timepoint [2] 9276 0
This is a one off measure at the end of the monitoring period (26 weeks post venous leg ulcer healing).
Secondary outcome [3] 9277 0
Adherence to treatment. This will be measured by a registered nurse attending an inperson data collection visit.
Timepoint [3] 9277 0
The first data collection will occur at 13 weeks following venous leg ulcer healing. The second data collection will occur at 26 weeks from the date the venous leg ulcer healed (therefore another 13 weeks later).

Eligibility
Key inclusion criteria
1. Any current client or new admission from any Royal District Nursing Service Site (includes people with diabetes).
2. The client is (within 1 week) completely healed of all lower leg ulcers (including both legs).
3. The last healed wound was a diagnosed venous leg ulcer
4. Ankle Brachial Pressure Index between 0.8 – 1.2 (undertaken at recruitment to the randomised controlled trial).
5. Client agrees to wear 4 layer compression bandaging for 2 weeks post healing and is prepared to participate in the randomised controlled trial which will mean the application of the randomised stocking at the completion of those two weeks.
6. Client is in the Home and Community Care (HACC) or Department of Veterans Affairs (DVA) program.
8. Any Fee for Service Program client to be considered on a case by case basis (contact Project Manager).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Client with fragile skin where the recruiter assesses there is a high risk of tearing the skin associated with the application of a compression stocking.
2. Client has peripheral vascular arterial disease based on previous diagnosis or signs of distal critical ischaemia such as dead toes, and or clear symptoms of intermittent claudication such as calf pain from exercise.
3. Peripheral neuropathy according to 10gr monofilament test (undertaken at recruitment to the randomised controlled trial).
4. Lymphoedema is the primary cause of the last healed wound
5. The last healed wound was malignant.
6. Clients with ankle circumference smaller than 19cm and / or calf circumference greater than 47cm.
7. Client is considered to be in the terminal stage of illness.

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)
Both the clinician and client are blinded to study allocation upon consenting to participate in the study. Allocation is concealed and clinicians will contact the central randomisation to get randomisation number and the group client is randomised to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence used for participant randomisation is generated using the random number function in Excel Microsoft software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4558 0
Charities/Societies/Foundations
Name [1] 4558 0
Sydney Myer Foundation
Country [1] 4558 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Royal District Nursing Service (RDNS) Helen Macpherson Smith Institute of Community Health
Address
31 Alma Rd St Kilda VIC 3182
Country
Australia
Secondary sponsor category [1] 4114 0
None
Name [1] 4114 0
Address [1] 4114 0
Country [1] 4114 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6608 0
Royal District Nursing Service Research Ethics Commitee
Ethics committee address [1] 6608 0
31 Alma Rd St Kilda VIC 3182
Ethics committee country [1] 6608 0
Australia
Date submitted for ethics approval [1] 6608 0
Approval date [1] 6608 0
28/10/2008
Ethics approval number [1] 6608 0
110

Summary
Brief summary
Managing and healing lower leg ulcers presents considerable challenges to the individuals who live with them and the health care providers involved in their care. Regrettably, lower leg ulcers frequently recur at rates of up to 69% among the most common type, venous leg ulcers (Kapp & Sayers, 2008). This is a frustrating and costly continuance which represents personal, social, financial and psychological costs to the individual and ongoing use of health care resources. Leg ulcers are estimated to affect 1.1 to 3.0 per thousand of the adult population in Australia and are estimated to cost our health care system A$3 billion per annum (Angel, Sieunarine, Abbas, & Mwipatayi, 2005). Royal District Nursing Service (RDNS) provided over 5,500 episodes of care to persons with leg ulcers in 2004 demonstrating the major contribution the agency makes to the management of a large percentage of Victorians living with these chronic recurrent wounds. An ageing population and an increase in the prevalence of chronic diseases (Australian Institute of Health and Welfare, 2004) suggests that chronic leg ulcers will continue to trouble Australians and continue to place demands on community health care services in the future.

Following a literature review recently completed at RDNS (Kapp & Sayers, 2008), it was identified that there is potential to improve and standardise practice in this area of health promotion and injury prevention. In response to the dilemma of leg ulcer recurrence RDNS sought and received funding from the Sidney Myer Foundation to conduct the ‘Forever Healed’ project which aims to prevent the recurrence of leg ulcers among a vulnerable, at risk group whilst at the same time optimising the potential for individuals to independently manage the underlying chronic disease which is the cause of the injury. This project fits perfectly within a Chronic Disease Management as well as an Active Service Model framework and thus has the potential to inform and improve the long term outcomes of all persons suffering from lower leg ulceration.

Forever Healed considers both new and existing RDNS clients who are receiving care for a venous leg ulcer. At the point of healing, clients will be invited to participate in a Randomised Controlled Trial comparing two types of commonly prescribed maintenance compression stockings. Clients will be reviewed at pre-detemined intervals for up to six months after their wound has healed. Evaluation of the Forever Healed project will include time to venous leg ulcer healing, recurrence and the number of ulcer free days subsequently experienced by the client. The cost of care associated with monitoring healed clients during the maintenance phase will be calculated.

In nearly all instances, management of the underlying condition which predisposes to venous ulceration is a life long commitment. Accordingly, the need for improvement in outcomes in this area of wound management is evident. In research by Chase, Melloni and Savage (1997) venous leg ulceration was described as ‘a forever healing process’ (p.74). The RDNS project ‘Forever Healed‘ aims to challenge the perception that ‘Forever Wounded’ is an expected outcome for many persons living with lower leg ulcers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29324 0
Address 29324 0
Country 29324 0
Phone 29324 0
Fax 29324 0
Email 29324 0
Contact person for public queries
Name 12571 0
Dr Lisa Donohue
Address 12571 0
Royal District Nursing Service, 31 Alma rd. St Kilda, VIC 3182
Country 12571 0
Australia
Phone 12571 0
+61 3 95365227
Fax 12571 0
Email 12571 0
[email protected]
Contact person for scientific queries
Name 3499 0
Suzanne Kapp
Address 3499 0
Royal District Nursing Service, 31 Alma rd. St Kilda, VIC 3182
Country 3499 0
Australia
Phone 3499 0
+61 3 95365336
Fax 3499 0
Email 3499 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

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