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Venous Leg UlcerETUVVENCT04714749

Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue (ETUVVE)

A study testing Endovenous treatment and Cyanoacrylate glue in people with Venous Leg Ulcer, run by Clinique Pasteur at 1 site in France.

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

Ulcers of the lower limbs are a major public health problem whose management needs to be further improved, particularly in terms of healing time, prevalence and recurrence rate. Ulcers of venous origin, or mixed arteriovenous and predominantly venous, represent the majority of leg ulcers with an estimated proportion… 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?
Endovenous treatment and Cyanoacrylate glue
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteFrance
Study dates
21 Jan 2021to 30 Jan 2024
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

  • Primary insufficiency of the great saphenous vein (GVS) by a reflux> 0.5 second from the inter-fascial saphenous trunk to the upper 1/3 of the thigh extending over the entire height of the thigh either in the saphenous compartment or in at least one extra-fascial tributary, in a standing patient, by compression of the calf
  • CEAP: C6, ulcer present on a single leg whose size can be captured by a simple photograph
  • Diameter of the GVS at the saphenofemoral junction ≥3 or ≤12 millimeters
  • Patient affiliated or beneficiary of a social security scheme
  • Patient having signed the informed consent

Who cannot join

  • Patient with a circumferential ulcer
  • Patient with ipsilateral small saphenous vein insufficiency
  • Presenting a serious current pathology and / or a life expectancy of less than 5 years
  • History of deep or superficial vein thrombosis in the previous 6 months
  • Patient with arteriopathy obliterating of the affected lower limb, with an IPS <0.8 or> 1.3
  • With post-thrombotic obstructive syndrome in the popliteal and / or femoral and / or iliac stage on the ipsilateral lower limb
Show all 16Show fewer
  • Presenting primary or post-thrombotic axial deep venous reflux on the ipsilateral lower limb
  • Suspicion of non-post-thrombotic iliac compression on Doppler ultrasound
  • Contraindication to the intended treatment technique
  • Known allergy to cyanoacrylate glue or xylocaine
  • Patient with a BMI greater than 40 (morbid obesity)
  • Patient whose geographical distance is not compatible with the follow-up of the study
  • Pregnant or breastfeeding woman
  • Patient participating in another clinical study
  • Patient linguistically or psychically unable to understand the information given, to give informed consent or to answer the study questionnaires.
  • Protected patients: Adults under some guardianship or other legal protection; Hospitalized without consent

Trial locations and contacts

1 site in 1 country.

France1 site

  • Clinique Pasteur Toulouse

    Toulouse, 31076

Other trials in France

About this study

Official title: Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue

Ulcers of the lower limbs are a major public health problem whose management needs to be further improved, particularly in terms of healing time, prevalence and recurrence rate. Ulcers of venous origin, or mixed arteriovenous and predominantly venous, represent the majority of leg ulcers with an estimated proportion of 70 to 80% of cases. These are painful, disabling conditions that are difficult to treat in a lasting way.

This study focuses on a treatment strategy with endovascular glue. The advantage of treating ulcers with cyanoacrylate glue is the possibility of occluding the great saphenous vein over its entire length, freeing itself from neurological complications secondary to endovenous thermal techniques (laser, radiofrequency), as well as the possibility of treating by direct puncture any perforators or tributaries feeding the ulcer.

This treatment strategy would improve the healing process for a lasting resolution of this pathology. This study aims to describe the feasibility and tolerance of this type of treatment in the resolution of varicose ulcers.

Being tested
Endovenous treatment, Cyanoacrylate glue
Keywords
endovenous treatment, glue
Medical subject headings
Varicose Ulcer

What participants receive

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

  • Endovenous treatmentProcedure or surgery

    Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue

  • Cyanoacrylate glueDevice

    Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue

Study groups in NCT04714749
Study groupRoleWhat they receive
Endovenous treatmentExperimentalEndovenous treatment with cyanoacrylate glue
Receives: Procedure: Endovenous treatment; Device: Cyanoacrylate glue

What is being measured

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

  1. Ulcer healing

    Proportion of patients who presented with healing of the venous ulcer

    Measured: Between surgery and 12 months after

Secondary outcomes (9)

  1. Functional and technical success

    Success assessed by occlusion of treated veins

    Measured: Day 0, Day 8, Month 1, Month 6 , Month 12

  2. VAS Pain

    Visual analogue scale (0-100 mm); higher is worse

    Measured: Day 0, Day 8, Month 1, Month 6 , Month 12

  3. Severity

    Clinical Venous Severity Score (CVSS); score between 0 to 30; higher is worse

    Measured: Day 0, Day 8, Month 1, Month 6 , Month 12

  4. Healing

    Time to ulcer healing

    Measured: Between surgery and 12 months after

  5. Ulcer duration

    Time without ulcer; time to recurrence (in days )

    Measured: Between surgery and 12 months after

  6. Ulcer recurrence

    Rate of recurrence

    Measured: Between surgery and 12 months after

  7. Symptoms

    VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire

    Measured: Day 0, Day 8, Month 1, Month 6 , Month 12

  8. Patient Quality of Life

    VEINES QOL (VEnous INsufficiency Epidemiologic and Economic Study- Quality Of Life) Questionnaire

    Measured: Day 0, Day 8, Month 1, Month 6 , Month 12

  9. Adverse events

    Adverse events related to glue or to the endovenous intervention

    Measured: Day 0, Day 8, Month 1, Month 6 , Month 12

Timeline

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

  1. First posted19 Jan 2021
  2. Study start21 Jan 2021
  3. Primary completion30 Jan 2024
  4. Study completion30 Jan 2024

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04714749
Sponsor's protocol ID
2020-A02799-30
Acronym
ETUVVE
Status last verified
Jun 2026
First submitted
13 Jan 2021
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gohel MS, Barwell JR, Taylor M, Chant T, Foy C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ. 2007 Jul 14;335(7610):83. doi: 10.1136/bmj.39216.542442.BE. Epub 2007 Jun 1.

    PubMed 17545185

  • Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.

    PubMed 29688123

  • Hirsch T. Varicose vein therapy and nerve lesions. Vasa. 2017 Mar;46(2):96-100. doi: 10.1024/0301-1526/a000588. Epub 2016 Dec 16.

    PubMed 27981883

  • Toonder IM, Lam YL, Lawson J, Wittens CH. Cyanoacrylate adhesive perforator embolization (CAPE) of incompetent perforating veins of the leg, a feasibility study. Phlebology. 2014 May;29(1 suppl):49-54. doi: 10.1177/0268355514529696. Epub 2014 May 19.

    PubMed 24843086

  • Morrison N, Gibson K, Vasquez M, Weiss R, Jones A. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):978-989. doi: 10.1016/j.jvsv.2019.12.080. Epub 2020 Mar 20.

    PubMed 32205125

  • Heatley F, Onida S, Davies AH. The global management of leg ulceration: Pre early venous reflux ablation trial. Phlebology. 2020 Sep;35(8):576-582. doi: 10.1177/0268355520917847. Epub 2020 Apr 8.

    PubMed 32268842

  • Abenhaim L, Kurz X. The VEINES study (VEnous Insufficiency Epidemiologic and Economic Study): an international cohort study on chronic venous disorders of the leg. VEINES Group. Angiology. 1997 Jan;48(1):59-66. doi: 10.1177/000331979704800110.

    PubMed 8995345

  • Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg. 2003 Feb;37(2):410-9. doi: 10.1067/mva.2003.152.

    PubMed 12563215

  • Kahn SR, Lamping DL, Ducruet T, Arsenault L, Miron MJ, Roussin A, Desmarais S, Joyal F, Kassis J, Solymoss S, Desjardins L, Johri M, Shrier I; VETO Study investigators. VEINES-QOL/Sym questionnaire was a reliable and valid disease-specific quality of life measure for deep venous thrombosis. J Clin Epidemiol. 2006 Oct;59(10):1049-56. doi: 10.1016/j.jclinepi.2005.10.016. Epub 2006 Jun 23.

    PubMed 16980144

  • Bland JM, Dumville JC, Ashby RL, Gabe R, Stubbs N, Adderley U, Kang'ombe AR, Cullum NA. Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial. BMC Cardiovasc Disord. 2015 Aug 11;15:85. doi: 10.1186/s12872-015-0080-7.

    PubMed 26260973

  • Nicolas Néaume, Fannie Forgues, Laurence Allouche, Sarah Bruni, Karol Chakkour, Clélia Dornier-Cassagneau, Philippe Léger, Nicolas Savy, Nicolas Mayeur, Treatment of venous leg ulcers by cyanoacrylate glue: A prospective study of safety and feasibility, JVS-Vascular Insights, Volume 4, 2026, 100393, ISSN 2949-9127, https://doi.org/10.1016/j.jvsvi.2026.100393.

Questions about this trial

What is this clinical trial studying?

A study testing Endovenous treatment and Cyanoacrylate glue in people with Venous Leg Ulcer, run by Clinique Pasteur at 1 site in France.

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 16 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 16 Jun 2026. 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 France. 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?

Ulcer healing (time frame: Between surgery and 12 months after). 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 NCT04714749, which also lists 11 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 16 Jun 2026.

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