Skip to main content
OpenTrials
Completed

NCT Number: NCT04011371

Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyanoacrylate closure

Procedure

Cyanoacrylate glue embolization targeting venous insufficiency

Primary outcomes

  1. Rate of adverse events

    Time frame: 3 months

  2. Healing rate

    Time frame: 3 months

    Change in ulcer size

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Medtronic Vascular

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 8, 2019
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.