Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

NCT04011371 | Completed

• 1 other identifier: 424-2017
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (2)

• Rate of adverse events

  3 months

• Healing rate

  Change in ulcer size

  3 months

Secondary Outcomes (4)

• Rate of adverse events

  12 months

• Healing rate

  12 months

• Closure rate

  12 months

• Patient-reported quality of life: EuroQol Five Dimension Scale: EQ-5D-5L Health Questionnaire

  12 months

Study Arms (1)

Cyanoacrylate closure

EXPERIMENTAL

Subjects enrolled in the study will undergo ultrasound guided vein closure using the VenaSealTM cyanoacrylate delivery device.

Procedure: Cyanoacrylate closure

Interventions

Cyanoacrylate closure PROCEDURE

Cyanoacrylate glue embolization targeting venous insufficiency

Cyanoacrylate closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Medtronic Vascular: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (13)

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  PMID: 8156326 RESULT

• 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.

  PMID: 11510598 RESULT

• 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.

  PMID: 9821029 RESULT

• 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.

  PMID: 15941430 RESULT

• 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.

  PMID: 10355863 RESULT

• 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.

  PMID: 7856198 RESULT

• 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.

  PMID: 10194512 RESULT

• 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.

  PMID: 10396491 RESULT

• 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.

  PMID: 17156107 RESULT

• 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.

  PMID: 26025146 RESULT

• 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.

  PMID: 25650040 RESULT

• 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.

  PMID: 26992340 RESULT

• 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.

  PMID: 26992985 RESULT

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 8, 2019
• Study Start: September 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)