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Perforator Vein Injection for Symptomatic Venous Disease (Dillavou)

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ClinicalTrials.gov Identifier: NCT03363633
Recruitment Status : Terminated (difficulty recruiting)
First Posted : December 6, 2017
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
American College of Phlebology
Information provided by (Responsible Party):
Ellen Dillavou, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Venous Disease
Interventions Drug: sodium tetradecyl sulfate
Device: Compression
Enrollment 12
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title All Arms
Hide Arm/Group Description Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
Period Title: Overall Study
Started 12
Completed 0 [1]
Not Completed 12
[1]
See note in Pre-Assignment Details
Arm/Group Title All Arms
Hide Arm/Group Description Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
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).
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: See note in Baseline Analysis Population Description
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
Female
Male
[1]
Measure Analysis Population Description: See note in Baseline Analysis Population Description
1.Primary Outcome
Title Ulcer Healing
Hide Description Change in wound size, reported in square centimeters
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title All Arms
Hide Arm/Group Description:
Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Venous Clinical Severity Score (VCSS)
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title All Arms
Hide Arm/Group Description:
Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Injection Complications
Hide Description Number of participants experiencing venous thromboses from injections
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title All Arms
Hide Arm/Group Description:
Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Compliance With Compression Therapy
Hide Description Number of participants who use compression therapy
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title All Arms
Hide Arm/Group Description:
Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Ulcer Recurrence
Hide Description Number of participants with ulcers that reopen after initial closure
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title All Arms
Hide Arm/Group Description:
Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description 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).
 
Arm/Group Title All Arms
Hide Arm/Group Description Participants were randomized to either compression stockings or perforator vein injection with sodium tetradecyl sulfate, plus compression stockings.
All-Cause Mortality
All Arms
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Arms
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Arms
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ellen D. Dillavou, MD, FACS
Organization: Duke University Medical Center
Responsible Party: Ellen Dillavou, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03363633     History of Changes
Other Study ID Numbers: Protocol #4
First Submitted: June 4, 2017
First Posted: December 6, 2017
Results First Submitted: December 18, 2017
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018