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Clinical Trials/ACTRN12609000416291
ACTRN12609000416291
Completed
Not Applicable

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.

Royal District Nursing Service (RDNS) Helen Macpherson Smith Institute of Community Health0 sites100 target enrollmentJune 5, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous leg ulcer recurrence
Sponsor
Royal District Nursing Service (RDNS) Helen Macpherson Smith Institute of Community Health
Enrollment
100
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 5, 2009
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Royal District Nursing Service (RDNS) Helen Macpherson Smith Institute of Community Health

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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