Trial Outcomes & Findings for Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements (NCT NCT03020446)
NCT ID: NCT03020446
Last Updated: 2020-11-27
Results Overview
decreased wound bed measured in centimeters
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
4 weeks
Results posted on
2020-11-27
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Sorbion in the Treatment of Venous Leg Ulcers The Protocol Elements
Baseline characteristics by cohort
| Measure |
Sorbion Dressing to Venous Leg Ulcer
n=3 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
67 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Study was terminated
decreased wound bed measured in centimeters
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study was termininated
visual assessment of decreased wound maceration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study was terminated
visual assessment of decreased wound necrosis
Outcome measures
Outcome data not reported
Adverse Events
Sorbion Dressing to Venous Leg Ulcer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place