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Provider of product no longer wished to continue with site. No data available.
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To follow the effectiveness of Sorbion Dressing in the treatment of highly exuding venous leg ulcers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorbion dressing to venous leg ulcer | Experimental | any venous leg ulcer will receive sorbion dressing weekly for 4 weeks than wound will be assessed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorbion Dressing | Device | Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Size | decreased wound bed measured in centimeters | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Maceration | visual assessment of decreased wound maceration | 4 weeks |
| Wound Necrosis | visual assessment of decreased wound necrosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Size | decreased wound bed measured in centimeters | Study was terminated | Posted | 4 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Munier Nazzal, MD | University of Toledo | 419-383-3576 | Munier.Nazzal@utoledo.edu |
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| 4 weeks |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Wound Maceration | visual assessment of decreased wound maceration | Study was termininated | Posted | 4 weeks |
|
|
| Secondary | Wound Necrosis | visual assessment of decreased wound necrosis | Study was terminated | Posted | 4 weeks |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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