Status:
COMPLETED
Community RCT of the Effectiveness of Two Compression Bandaging Technologies
Lead Sponsor:
Queen's University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Venous Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Leg ulcers are emotionally distressing and painful, and often require months or years to heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a common, complex, and ...
Detailed Description
Background: Although rarely recognized as a pressing health care problem, leg ulcers comprise a common, complex, and costly condition. Over 80% of ongoing management of chronic wounds occurs in the c...
Eligibility Criteria
Inclusion
- clinical presentation of venous insufficiency
- leg ulcer equal to or larger than 0.7 cm in any one dimension
- ulcer a minimum duration of 1 week
- ankle brachial pressure index equal to or greater than 0.80
- participant can provide written consent
- participant can communicate in English, or translation available
- participant 18 years or over
Exclusion
- diagnosed with Diabetes Mellitus - insulin dependent or participant on oral hypoglycemics
- participants who failed to improve over a 3-month period after being treated with either the SS or 4-layer compression bandaging system prior to the trial
- previous trial patients (ie individuals previously enrolled in the study but now have recurrence or a new ulcer)
- symptoms of cognitive impairment noted
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT00202267
Start Date
January 1 2004
End Date
December 1 2008
Last Update
November 20 2015
Active Locations (15)
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1
Winnipeg Regional Health Authority
Winnipeg, Manitoba, Canada, R3G 0N6
2
Nursing Practice Solutions
Fort Erie, Ontario, Canada, L2A 2G4
3
VON Hamilton Branch
Hamilton, Ontario, Canada, L8L 5G8
4
Saint Elizabeth Health Care
Kingston, Ontario, Canada, K7L 1G8