Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Venous Leg Ulcer Clinical Trial

Official title:

Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011371
• Other study ID #: 424-2017
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: April 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Procedure:
• Cyanoacrylate closure
Cyanoacrylate glue embolization targeting venous insufficiency

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Medtronic Vascular

Country where clinical trial is conducted

Canada, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. doi: 10.1002/bjs.1800810204. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 10.10 — View Citation

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. — View Citation

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- — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse events		3 months
Primary	Healing rate	Change in ulcer size	3 months
Secondary	Rate of adverse events		12 months
Secondary	Healing rate	Change in ulcer size	12 months
Secondary	Closure rate	Time to ulcer closure	12 months
Secondary	Patient-reported quality of life: EuroQol Five Dimension Scale: EQ-5D-5L Health Questionnaire	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.	12 months