Venous Wound Ulcers
Conditions
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.
Interventions
DEVICESorbion Dressing
Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks
Sponsors
University of Toledo Health Science Campus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* venous leg ulcer
Exclusion criteria
* pregnant females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Size | 4 weeks | decreased wound bed measured in centimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Maceration | 4 weeks | visual assessment of decreased wound maceration |
| Wound Necrosis | 4 weeks | visual assessment of decreased wound necrosis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Sorbion Dressing to Venous Leg Ulcer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 67 years |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Wound Size
decreased wound bed measured in centimeters
Time frame: 4 weeks
Population: Study was terminated
Secondary
Wound Maceration
visual assessment of decreased wound maceration
Time frame: 4 weeks
Population: Study was termininated
Secondary
Wound Necrosis
visual assessment of decreased wound necrosis
Time frame: 4 weeks
Population: Study was terminated