Cyanoacrylate Closure for Treatment of Venous Leg Ulcers
NCT ID: NCT04011371
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2019-09-01
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cyanoacrylate closure
Subjects enrolled in the study will undergo ultrasound guided vein closure using the VenaSealTM cyanoacrylate delivery device.
Cyanoacrylate closure
Cyanoacrylate glue embolization targeting venous insufficiency
Interventions
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Cyanoacrylate closure
Cyanoacrylate glue embolization targeting venous insufficiency
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. doi: 10.1002/bjs.1800810204.
Fowkes FG, Evans CJ, Lee AJ. Prevalence and risk factors of chronic venous insufficiency. Angiology. 2001 Aug;52 Suppl 1:S5-15. doi: 10.1177/0003319701052001S02.
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, Lastoria S. Venous ulcer: epidemiology, physiopathology, diagnosis and treatment. Int J Dermatol. 2005 Jun;44(6):449-56. doi: 10.1111/j.1365-4632.2004.02456.x.
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. doi: 10.1177/1358836X9900400101.
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, Nelzen O. Chronic leg ulcers: the impact of venous disease. J Vasc Surg. 1999 Apr;29(4):752-5. doi: 10.1016/s0741-5214(99)70330-7. No abstract available.
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. doi: 10.1136/jech.53.3.149.
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. doi: 10.1046/j.1524-475X.1994.20305.x.
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.
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. No abstract available.
Other Identifiers
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424-2017
Identifier Type: -
Identifier Source: org_study_id
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