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

Not Applicable

Terminated

• Conditions: Venous Wound Ulcers
• Interventions: Device: Sorbion Dressing

• Registration Number: NCT03020446
• Lead Sponsor: University of Toledo Health Science Campus

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-10-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Status Verified: 2020-11
• Results First Submitted: 2020-11-03
• Results First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Results First Posted: 2020-11-27
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• venous leg ulcer

Exclusion Criteria

• pregnant females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorbion dressing to venous leg ulcer	Sorbion Dressing	any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed

Primary Outcome Measures

Name	Time	Method
Wound Size	4 weeks	decreased wound bed measured in centimeters

Secondary Outcome Measures

Name	Time	Method
Wound Maceration	4 weeks	visual assessment of decreased wound maceration
Wound Necrosis	4 weeks	visual assessment of decreased wound necrosis

Trial Locations

Locations (1)

University of Toledo Medical Center; 🇺🇸 Toledo, Ohio, United States