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

Status

Terminated

Conditions

Intervention / Treatment

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

  • United States
    • Ohio
      • 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
Device: Sorbion Dressing
Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks
Other Names:
  • Sorbion Sachet sorbion sana

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.

Sponsor

University of Toledo Health Science Campus

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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