ANZCTR - Registration

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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]

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

Condition category

Condition code

Other

Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Physical Medicine / Rehabilitation

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]

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]

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]

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]

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]

This is a one off measure at the end of the monitoring period (26 weeks post venous leg ulcer healing).

Secondary outcome [2]

Participant satisfaction. This involves a satisfaction survey administeded to all participants.

Timepoint [2]

This is a one off measure at the end of the monitoring period (26 weeks post venous leg ulcer healing).

Secondary outcome [3]

Adherence to treatment. This will be measured by a registered nurse attending an inperson data collection visit.

Timepoint [3]

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?

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]

Charities/Societies/Foundations

Name [1]

Sydney Myer Foundation

Address [1]

Level 18
8 Exhibition Street
Melbourne, Victoria 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal District Nursing Service Research Ethics Commitee

Ethics committee address [1]

31 Alma Rd St Kilda VIC 3182

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/10/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Lisa Donohue

Address

Royal District Nursing Service, 31 Alma rd. St Kilda, VIC 3182

Country

Australia

Phone

+61 3 95365227

Fax

ldonohue@rdns.com.au

Contact person for scientific queries

Name

Suzanne Kapp

Address

Royal District Nursing Service, 31 Alma rd. St Kilda, VIC 3182

Country

Australia

Phone

+61 3 95365336

Fax

skapp@rdns.com.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.

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