Back to resultsEffectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements (Sorbion)
Primary Purpose
Venous Wound Ulcers
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sorbion Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Venous Wound Ulcers
Eligibility Criteria
Inclusion Criteria:
- venous leg ulcer
Exclusion Criteria:
- pregnant females
Sites / Locations
- University of Toledo Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sorbion dressing to venous leg ulcer
Arm Description
any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed
Outcomes
Primary Outcome Measures
Wound Size
decreased wound bed measured in centimeters
Secondary Outcome Measures
Wound Maceration
visual assessment of decreased wound maceration
Wound Necrosis
visual assessment of decreased wound necrosis
Full Information
NCT ID
NCT03020446
First Posted
October 7, 2015
Last Updated
November 3, 2020
Sponsor
University of Toledo Health Science Campus
1. Study Identification
Unique Protocol Identification Number
NCT03020446
Brief Title
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
Acronym
Sorbion
Official Title
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Provider of product no longer wished to continue with site. No data available.
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Wound Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sorbion dressing to venous leg ulcer
Arm Type
Experimental
Arm Description
any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed
Intervention Type
Device
Intervention Name(s)
Sorbion Dressing
Other Intervention Name(s)
Sorbion Sachet sorbion sana
Intervention Description
Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks
Primary Outcome Measure Information:
Title
Wound Size
Description
decreased wound bed measured in centimeters
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Wound Maceration
Description
visual assessment of decreased wound maceration
Time Frame
4 weeks
Title
Wound Necrosis
Description
visual assessment of decreased wound necrosis
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
venous leg ulcer
Exclusion Criteria:
pregnant females
Facility Information:
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
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