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Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011371
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Medtronic Vascular
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Venous Leg Ulcer Procedure: Cyanoacrylate closure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyanoacrylate Closure for Treatment of Venous Leg Ulcers
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cyanoacrylate closure
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




Primary Outcome Measures :
  1. Rate of adverse events [ Time Frame: 3 months ]
  2. Healing rate [ Time Frame: 3 months ]
    Change in ulcer size


Secondary Outcome Measures :
  1. Rate of adverse events [ Time Frame: 12 months ]
  2. Healing rate [ Time Frame: 12 months ]
    Change in ulcer size

  3. Closure rate [ Time Frame: 12 months ]
    Time to ulcer closure

  4. Patient-reported quality of life: EuroQol Five Dimension Scale: EQ-5D-5L Health Questionnaire [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011371


Contacts
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Contact: Ahmed Kayssi, MD MSc MPH 416-480-6948 ahmed.kayssi@sunnybrook.ca
Contact: Leslie Summers deLuca, PhD 416-480-6100 ext 2593 leslie.summersdeluca@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Leslie Summers deLuca, PhD    416-480-6100 ext 2593    leslie.summersdeluca@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Medtronic Vascular
Publications of Results:

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04011371    
Other Study ID Numbers: 424-2017
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varicose Ulcer
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases