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Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Primary Purpose

Venous Leg Ulcer

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Cyanoacrylate closure

About this trial

This is an interventional treatment trial for Venous Leg Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyanoacrylate closure

Arm Description

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

Outcomes

Primary Outcome Measures

Rate of adverse events

Healing rate

Change in ulcer size

Secondary Outcome Measures

Rate of adverse events

Healing rate

Change in ulcer size

Closure rate

Time to ulcer closure

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.

Full Information

NCT ID

NCT04011371

First Posted

July 5, 2019

Last Updated

April 12, 2023

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Medtronic Vascular

1. Study Identification

Unique Protocol Identification Number

NCT04011371

Brief Title

Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Official Title

Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Medtronic Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cyanoacrylate closure

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Cyanoacrylate closure

Intervention Description

Cyanoacrylate glue embolization targeting venous insufficiency

Primary Outcome Measure Information:

Title

Rate of adverse events

Time Frame

3 months

Title

Healing rate

Description

Change in ulcer size

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Rate of adverse events

Time Frame

12 months

Title

Healing rate

Description

Change in ulcer size

Time Frame

12 months

Title

Closure rate

Description

Time to ulcer closure

Time Frame

12 months

Title

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

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N3M5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

8156326

Citation

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

Results Reference

result

PubMed Identifier

11510598

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.

Results Reference

result

PubMed Identifier

9821029

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.

Results Reference

result

PubMed Identifier

15941430

Citation

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.

Results Reference

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PubMed Identifier

10355863

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.

Results Reference

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PubMed Identifier

7856198

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.

Results Reference

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PubMed Identifier

10194512

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.

Results Reference

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PubMed Identifier

10396491

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.

Results Reference

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PubMed Identifier

17156107

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.

Results Reference

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PubMed Identifier

26025146

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.

Results Reference

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PubMed Identifier

25650040

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: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.

Results Reference

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PubMed Identifier

26992340

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.

Results Reference

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PubMed Identifier

26992985

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):105-6. doi: 10.1016/j.jvsv.2013.10.009. Epub 2013 Dec 12. No abstract available.

Results Reference

result

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Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

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