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

NCT ID: NCT03020446

Last Updated: 2020-11-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Venous Wound Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sorbion dressing to venous leg ulcer

any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed

Group Type EXPERIMENTAL

Sorbion Dressing

Intervention Type DEVICE

Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks

Interventions

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Sorbion Dressing

Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks

Intervention Type DEVICE

Other Intervention Names

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Sorbion Sachet sorbion sana

Eligibility Criteria

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Inclusion Criteria

* venous leg ulcer

Exclusion Criteria

* pregnant females
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toledo Health Science Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Toledo Medical Center

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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Sorbion Study

Identifier Type: -

Identifier Source: org_study_id