None listed
Conditions
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.
Interventions
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 in
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.
Sponsors
Royal District Nursing Service (RDNS) Helen Macpherson Smith Institute of Community Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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).
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.
Outcome results
None listed