Trial Outcomes & Findings for Venous Occlusion and Limb Swelling (NCT NCT02241343)
NCT ID: NCT02241343
Last Updated: 2020-11-24
Results Overview
Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
30 minutes
Results posted on
2020-11-24
Participant Flow
Participant milestones
| Measure |
Trial Cohort
All participants
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Trial Cohort
All participants
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Trial Cohort
n=1 Participants
All participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
|
Sex/Gender, Customized
Male
|
1 participants
n=1 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: Adverse event precluded data collection
Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 minutesPopulation: Zero analysed due to adverse event during protocol
Great saphenous vein diameter at the knee, taken with duplex ultrasound (cm)
Outcome measures
Outcome data not reported
Adverse Events
Trial Cohort
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trial Cohort
n=1 participants at risk
|
|---|---|
|
Investigations
Faint
|
100.0%
1/1 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place