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Venous Leg UlcerNCT04011371

Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

A study testing Cyanoacrylate closure in people with Venous Leg Ulcer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Leg Ulcer
What is being tested?
Cyanoacrylate closure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteCanada
Study dates
1 Sep 2019to 1 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5

Other trials in Canada

About this study

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.

Being tested
Cyanoacrylate closure
Medical subject headings
Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cyanoacrylate closureProcedure or surgery

    Cyanoacrylate glue embolization targeting venous insufficiency

Study groups in NCT04011371
Study groupRoleWhat they receive
Cyanoacrylate closureExperimentalSubjects enrolled in the study will undergo ultrasound guided vein closure using the VenaSealTM cyanoacrylate delivery device.
Receives: Procedure: Cyanoacrylate closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of adverse events

    Measured: 3 months

  2. Healing rate

    Change in ulcer size

    Measured: 3 months

Secondary outcomes (4)

  1. Rate of adverse events

    Measured: 12 months

  2. Healing rate

    Change in ulcer size

    Measured: 12 months

  3. Closure rate

    Time to ulcer closure

    Measured: 12 months

  4. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2019
  2. Study start1 Sep 2019
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04011371
Sponsor's protocol ID
424-2017
Status last verified
Apr 2023
First submitted
5 Jul 2019
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 8156326

  • 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.

    PubMed 11510598

  • 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.

    PubMed 9821029

  • 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.

    PubMed 15941430

  • 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.

    PubMed 10355863

  • 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.

    PubMed 7856198

  • 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.

    PubMed 10194512

  • 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.

    PubMed 10396491

  • 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.

    PubMed 17156107

  • 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.

    PubMed 26025146

  • 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.

    PubMed 25650040

  • 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.

    PubMed 26992340

  • 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.

    PubMed 26992985

Questions about this trial

What is this clinical trial studying?

A study testing Cyanoacrylate closure in people with Venous Leg Ulcer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of adverse events (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04011371, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.

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