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

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Procedure: Endovenous treatment; Device: Cyanoacrylate glue

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas NEAUME, MD; Phone Number: +33 5 61 16 13 01; Email: nneaume@clinique-pasteur.com

Study Locations

• France
  • Toulouse, France, 31076
    • Clinique Pasteur Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovenous treatment; Endovenous treatment with cyanoacrylate glue	Procedure: Endovenous treatment; Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue; Device: Cyanoacrylate glue; Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ulcer healing	Proportion of patients who presented with healing of the venous ulcer	Between surgery and 12 months after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional and technical success	Success assessed by occlusion of treated veins	Day 0, Day 8, Month 1, Month 6 , Month 12
VAS Pain	Visual analogue scale (0-100 mm); higher is worse	Day 0, Day 8, Month 1, Month 6 , Month 12
Severity	Clinical Venous Severity Score (CVSS); score between 0 to 30; higher is worse	Day 0, Day 8, Month 1, Month 6 , Month 12
Healing	Time to ulcer healing	Between surgery and 12 months after
Ulcer duration	Time without ulcer; time to recurrence (in days )	Between surgery and 12 months after
Ulcer recurrence	Rate of recurrence	Between surgery and 12 months after
Symptoms	VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire	Day 0, Day 8, Month 1, Month 6 , Month 12
Patient Quality of Life	VEINES QOL (VEnous INsufficiency Epidemiologic and Economic Study- Quality Of Life) Questionnaire	Day 0, Day 8, Month 1, Month 6 , Month 12
Adverse events	Adverse events related to glue or to the endovenous intervention	Day 0, Day 8, Month 1, Month 6 , Month 12

Collaborators and Investigators

• Sponsor: Clinique Pasteur
• Investigators: Principal Investigator: Nicolas NEAUME, MD, Clinique Pasteur

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: J Clin Epidemiol. 2006 Dec;59(12):1334.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: endovenous treatment; glue
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: 2020-A02799-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No