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出境医 / 临床实验 / Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
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
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Rate of adverse events [ Time Frame: 3 months ]
  • Healing rate [ Time Frame: 3 months ]
    Change in ulcer size
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
  • Rate of adverse events [ Time Frame: 12 months ]
  • Healing rate [ Time Frame: 12 months ]
    Change in ulcer size
  • Closure rate [ Time Frame: 12 months ]
    Time to ulcer closure
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Rate of adverse events [ Time Frame: 12 months ]
  • Healing rate [ Time Frame: 12 months ]
    Change in ulcer size
  • Closure rate [ Time Frame: 12 months ]
    Time to ulcer closure
  • Patient-reported quality of life [ Time Frame: 12 months ]
    EQ-5D
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cyanoacrylate Closure for Treatment of Venous Leg Ulcers
Official Title  ICMJE Cyanoacrylate Closure for Treatment of Venous Leg Ulcers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Venous Leg Ulcer
Intervention  ICMJE Procedure: Cyanoacrylate closure
Cyanoacrylate glue embolization targeting venous insufficiency
Study Arms  ICMJE Experimental: Cyanoacrylate closure
Subjects enrolled in the study will undergo ultrasound guided vein closure using the VenaSealTM cyanoacrylate delivery device.
Intervention: Procedure: Cyanoacrylate closure
Publications *
  • Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. Review.
  • Fowkes FG, Evans CJ, Lee AJ. Prevalence and risk factors of chronic venous insufficiency. Angiology. 2001 Aug;52 Suppl 1:S5-15.
  • Van den Oever R, Hepp B, Debbaut B, Simon I. Socio-economic impact of chronic venous insufficiency. An underestimated public health problem. Int Angiol. 1998 Sep;17(3):161-7.
  • Abbade LP, Lastória S. Venous ulcer: epidemiology, physiopathology, diagnosis and treatment. Int J Dermatol. 2005 Jun;44(6):449-56. Review.
  • Olin JW, Beusterien KM, Childs MB, Seavey C, McHugh L, Griffiths RI. Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study. Vasc Med. 1999;4(1):1-7.
  • Mayer W, Jochmann W, Partsch H. [Varicose ulcer: healing in conservative therapy. A prospective study]. Wien Med Wochenschr. 1994;144(10-11):250-2. German.
  • Bergqvist D, Lindholm C, Nelzén O. Chronic leg ulcers: the impact of venous disease. J Vasc Surg. 1999 Apr;29(4):752-5.
  • Evans CJ, Fowkes FG, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health. 1999 Mar;53(3):149-53.
  • Lazarus GS, Cooper DM, Knighton DR, Percoraro RE, Rodeheaver G, Robson MC. Definitions and guidelines for assessment of wounds and evaluation of healing. Wound Repair Regen. 1994 Jul;2(3):165-70.
  • Kelechi TJ, Johnson JJ, Yates S. Chronic venous disease and venous leg ulcers: An evidence-based update. J Vasc Nurs. 2015 Jun;33(2):36-46. doi: 10.1016/j.jvn.2015.01.003. Review.
  • Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
  • Almeida JI, Javier JJ, Mackay E, Bautista C, Proebstle TM. First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous Lymphat Disord. 2013 Apr;1(2):174-80. doi: 10.1016/j.jvsv.2012.09.010. Epub 2012 Dec 22.
  • Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Davies A. Twelve-Month Follow-up of the European Multicenter Study on Cyanoacrylate Embolization of Incompetent Great Saphenous Veins. J Vasc Surg Venous Lymphat Disord. 2014 Jan;2(1):105-6. doi: 10.1016/j.jvsv.2013.10.009. Epub 2013 Dec 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011371
Other Study ID Numbers  ICMJE 424-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Medtronic Vascular
Investigators  ICMJE Not Provided
PRS Account Sunnybrook Health Sciences Centre
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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