Status:
COMPLETED
Cyanoacrylate Closure for Treatment of Venous Leg Ulcers
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Medtronic Vascular
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-thr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04011371
Start Date
September 1 2019
End Date
June 1 2022
Last Update
April 13 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5