Forever Healed: Breaking the cycle of wound recurrence among persons with chronic leg ulceratio

Completed

• Conditions: Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis); Venous leg ulcer recurrence

• Registration Number: ACTRN12609000416291
• Lead Sponsor: Royal District Nursing Service (RDNS) Helen Macpherson Smith Institute of Community Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[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 Measures

Name	Time	Method
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.[This is a one off measure at the end of the monitoring period (26 weeks post venous leg ulcer healing).];Participant satisfaction. This involves a satisfaction survey administeded to all participants.[This is a one off measure at the end of the monitoring period (26 weeks post venous leg ulcer healing).];Adherence to treatment. This will be measured by a registered nurse attending an inperson data collection visit.[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).]