Completed

Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

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What is being tested

Cyanoacrylate closure

Procedure
Who is being recruted

Cardiovascular Diseases+5

+ Leg Ulcer

+ Skin Diseases

Over 18 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2019
See protocol details

Summary

Principal SponsorSunnybrook Health Sciences Centre
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2019

Actual date on which the first participant was enrolled.

Venous leg ulcers (VLUs) are a common wound with significant morbidity and cost, and suboptimal therapeutic options. VLUs result from chronic venous insufficiency, including venous reflux and post-thrombotic syndrome. VLU can take from months to years to heal, and 54-78% recur. Current therapies include wound, compression therapy, and medications. These treatments can increase the rate of healing, and reduce recurrence, however these therapies can be burdensome, painful, and ineffective, and despite these therapies, \~50% of wounds become chronic. Chronic VLUs can be painful, malodorous, and infected, and they often significantly limit an individual's function and mobility. An emerging therapy for symptomatic venous reflux is the closure of the culprit vein by endovenous closure with a cyanoacrylate adhesive implant. Recent studies show cyanoacrylate closure (CAC) to be a safe and effective treatment for varicosities resulting from symptomatic incompetent great saphenous veins. This study will evaluate the safety and effectiveness of CAC for VLUs.

Official TitleCyanoacrylate Closure for Treatment of Venous Leg Ulcers
NCT04011371
Principal SponsorSunnybrook Health Sciences Centre
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesLeg UlcerSkin DiseasesSkin UlcerVaricose UlcerVaricose VeinsVascular DiseasesSkin and Connective Tissue Diseases

Criteria

5 inclusion criteria required to participate
Age ≥18 years old at time of screening;

Venous leg ulcer;

Venous insufficiency (>0.5 seconds; confirmed by Doppler within last 6 months);

ABI of ≥0.9;

Show More Criteria

18 exclusion criteria prevent from participating
Previous hypersensitivity reactions to the VenaSealTM adhesive or cyanoacrylates;

Acute superficial thrombophlebitis;

Bilateral treatment

Thrombophlebitis migrans;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects enrolled in the study will undergo ultrasound guided vein closure using the VenaSealTM cyanoacrylate delivery device.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sunnybrook Health Sciences Centre

Toronto, CanadaOpen Sunnybrook Health Sciences Centre in Google Maps
CompletedOne Study Center
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