- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03020446
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements (Sorbion)
November 3, 2020 updated by: University of Toledo Health Science Campus
To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.
Study Overview
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 Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
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Toledo, Ohio, United States, 43614
- University of Toledo Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- venous leg ulcer
Exclusion Criteria:
- pregnant females
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sorbion dressing to venous leg ulcer
any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed
|
Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Size
Time Frame: 4 weeks
|
decreased wound bed measured in centimeters
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Maceration
Time Frame: 4 weeks
|
visual assessment of decreased wound maceration
|
4 weeks
|
Wound Necrosis
Time Frame: 4 weeks
|
visual assessment of decreased wound necrosis
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
October 7, 2015
First Submitted That Met QC Criteria
January 11, 2017
First Posted (Estimate)
January 13, 2017
Study Record Updates
Last Update Posted (Actual)
November 27, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sorbion Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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