Trial Outcomes & Findings for Perforator Vein Injection for Symptomatic Venous Disease (NCT NCT03363633)
NCT ID: NCT03363633
Last Updated: 2018-02-23
Results Overview
Change in wound size, reported in square centimeters
TERMINATED
NA
12 participants
12 months
2018-02-23
Participant Flow
The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).
Participant milestones
| Measure |
All Arms
Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
See note in Baseline Analysis Population Description
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).
Change in wound size, reported in square centimeters
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).
The VCSS includes nine criteria of chronic venous disease, each graded from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Up to three points may be added for differences in background conservative therapy (compression and elevation). The scores are then added, with a maximum score of 30.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).
Number of participants experiencing venous thromboses from injections
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).
Number of participants who use compression therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).
Number of participants with ulcers that reopen after initial closure
Outcome measures
Outcome data not reported
Adverse Events
All Arms
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