Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements

Venous Wound Ulcers Clinical Trial

— Sorbion  

Official title:

Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03020446
• Other study ID #: Sorbion Study
• Status: Terminated
• Phase: N/A
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2020
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• venous leg ulcer

Exclusion Criteria:

• pregnant females

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Wound Ulcers

Intervention

Device:
• Sorbion Dressing
Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks

Locations

Country	Name	City	State
United States	University of Toledo Medical Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Size	decreased wound bed measured in centimeters	4 weeks
Secondary	Wound Maceration	visual assessment of decreased wound maceration	4 weeks
Secondary	Wound Necrosis	visual assessment of decreased wound necrosis	4 weeks