Clinical Trials Directory

Trials / Completed

CompletedNCT04011371

Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Sunnybrook Health Sciences Centre · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECyanoacrylate closureCyanoacrylate glue embolization targeting venous insufficiency

Timeline

Start date
2019-09-01
Primary completion
2022-06-01
Completion
2022-06-01
First posted
2019-07-08
Last updated
2023-04-13

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04011371. Inclusion in this directory is not an endorsement.