Status:
COMPLETED
Interdisciplinary Pressure Management & Mobility Program as an Alternative to Usual Care: A Pilot Study
Lead Sponsor:
University of Western Ontario, Canada
Collaborating Sponsors:
Ontario Neurotrauma Foundation
Conditions:
Pressure Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
People with spinal cord injuries posses many factors that increase their risk of developing pressure ulcers. Not surprisingly, approximately 82% of persons with spinal cord injury (SCI) will experienc...
Detailed Description
Hypothesis: Individuals with SCI who have pressure ulcers who receive an individualized, community-based, pressure management and mobility program will have better outcomes compared to a similar group...
Eligibility Criteria
Inclusion
- Adults (18-80 yrs) with a spinal cord injury (SCI) resulting in quadriplegia or paraplegia
- Stage II-IV pressure ulcer located anywhere on the body that is likely to heal over the 6 month study period.
- Requires a wheelchair for locomotion
- Able to travel to local wound centre to undergo detailed wound and medical assessment that includes blood analysis and wound culture.
- Provides consent to access relevant medical records.
- Able to adhere with study protocol, pressure management and mobility program, wound care protocol, and evaluation procedures for 8 month study period.
Exclusion
- Unable to achieve adequate pressure relief using available resources provided by research study.
- Stage IV deep pressure sore +/- osteomyelitis that requires surgical closure.
- Medically unstable or has or any other medical condition that would prevent the individual from sitting in wheelchair for at least 2 hours (e.g. Orthostatic hypotension).
- Has a limited life expectancy that is not sufficient to complete the study.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00796042
Start Date
January 1 2008
End Date
January 1 2010
Last Update
June 5 2012
Active Locations (2)
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1
University of Western Ontario
London, Ontario, Canada
2
Women's College Hospital & Mississauga Dermatology Clinic
Toronto & Mississauga, Ontario, Canada