Clinical trial NCT04011371: Cyanoacrylate Closure for Treatment of Venous Leg Ulcers
Official title: Cyanoacrylate Closure for Treatment of Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Medtronic Vascular
First posted: 2019-07-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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-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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old at time of screening;
2. Venous leg ulcer;
3. Venous insufficiency (\>0.5 seconds; confirmed by Doppler within last 6 months);
4. ABI of ≥0.9;
5. Capable of understanding the study and providing informed consent.

Exclusion Criteria:

1. Previous hypersensitivity reactions to the VenaSealTM adhesive or cyanoacrylates;
2. Acute superficial thrombophlebitis;
3. Bilateral treatment
4. Thrombophlebitis migrans;
5. Deep venous thrombosis;
6. 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);
7. Post-thrombotic syndrome;
8. Acute sepsis;
9. Coagulation disorders;
10. Radiation or chemotherapy within 3 months of study;
11. Pregnant or lactating females;
12. Uncontrolled diabetes (HbA1c \>10%);
13. Diabetic foot ulcers;
14. Current use of systemic anticoagulation;
15. Previous treatment of target vein;
16. Tortuous veins;
17. Current participation in another interventional study, or participation within 30 days prior to screening;
18. Inability to tolerate compression, or to receive endovenous treatment.

Primary outcomes:
measure: Rate of adverse events
timeFrame: 3 months
measure: Healing rate
timeFrame: 3 months
Secondary outcomes:
measure: Rate of adverse events
timeFrame: 12 months
measure: Healing rate
timeFrame: 12 months
measure: Closure rate
timeFrame: 12 months
measure: Patient-reported quality of life: EuroQol Five Dimension Scale: EQ-5D-5L Health Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
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