NCT03020446TerminatedNot Applicable
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
University of Toledo Health Science Campus1 site in 1 country3 target enrollmentStarted: July 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Wound Size
Study Overview
Brief Summary
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.
Detailed Description
Wounds will be assessed for inclusion into the study, digital images of the wound will be taken, wound will be cleansed, a sorbion dressing will be placed on wound and a cover dressing with be used to keep in place. The wound will be assessed and a dressing change will take place weekly for 4 weeks. At the final visit a final wound evaluation will be done.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •venous leg ulcer
Exclusion Criteria
- •pregnant females
Arms & Interventions
Sorbion dressing to venous leg ulcer
Experimental
any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed
Intervention: Sorbion Dressing (Device)
Outcomes
Primary Outcomes
Wound Size
Time Frame: 4 weeks
decreased wound bed measured in centimeters
Secondary Outcomes
- Wound Maceration(4 weeks)
- Wound Necrosis(4 weeks)
Investigators
Study Sites (1)
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