Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Study Overview
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Brief Summary
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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 Title
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Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Procedure: Cyanoacrylate closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Capable of understanding the study and providing informed consent. Exclusion Criteria: Previous hypersensitivity reactions to the VenaSealTM adhesive or cyanoacrylates; Acute superficial thrombophlebitis; Bilateral treatment Thrombophlebitis migrans; Deep venous thrombosis; Deep venous incompetence or occlusion in external iliac or distal veins in the affected extremity (as assessed based on spontaneity, phasicity, augmentation, pulsatility, and compressibility on ultrasound); Post-thrombotic syndrome; Acute sepsis; Coagulation disorders; Radiation or chemotherapy within 3 months of study; Pregnant or lactating females; Uncontrolled diabetes (HbA1c >10%); Diabetic foot ulcers; Current use of systemic anticoagulation; Previous treatment of target vein; Tortuous veins; Current participation in another interventional study, or participation within 30 days prior to screening; Inability to tolerate compression, or to receive endovenous treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyanoacrylate closure<br>Subjects enrolled in the study will undergo ultrasound guided vein closure using the VenaSealTM cyanoacrylate delivery device. | Procedure: Cyanoacrylate closure<br>* Cyanoacrylate glue embolization targeting venous insufficiency<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events |  | 3 months | 
| Healing rate | Change in ulcer size | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events |  | 12 months | 
| Healing rate | Change in ulcer size | 12 months | 
| Closure rate | Time to ulcer closure | 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. | 12 months |