An interventional study of Cyanoacrylate closure in Venous Leg Ulcer, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
377 studies on the registry are indexed under Varicose Ulcer; 79 are open to participants now.
This study's enrollment of 21 is below the median of 65 across 324 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects enrolled in the study will undergo ultrasound guided vein closure using the VenaSealTM cyanoacrylate delivery device.
Procedure: Cyanoacrylate closure
Cyanoacrylate glue embolization targeting venous insufficiency
Rate of adverse events
Time frame: 3 months
Healing rate
Change in ulcer size
Time frame: 3 months
Rate of adverse events
Time frame: 12 months
Healing rate
Change in ulcer size
Time frame: 12 months
Closure rate
Time to ulcer closure
Time frame: 12 months
Patient-reported quality of life: EuroQol Five Dimension Scale: EQ-5D-5L Health Questionnaire
EuroQol Five Dimension Scale: EQ-5D-5L Health Questionnaire - measures patient-reported health related to five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses for each parameter are coded 1-5, with a lower score reflecting better health, and a higher score meaning worse health. Overall health is self-rated on a scale 0-100, with 0 meaning the worst and 100 meaning the best health imaginable.
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre