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

Venous Leg Ulcer Clinical Trial

— ETUVVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714749
• Other study ID #: 2020-A02799-30
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2024
• Source: Clinique Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
France	Clinique Pasteur Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Pasteur

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer healing	Proportion of patients who presented with healing of the venous ulcer	Between surgery and 12 months after
Secondary	Functional and technical success	Success assessed by occlusion of treated veins	Day 0, Day 8, Month 1, Month 6 , Month 12
Secondary	VAS Pain	Visual analogue scale (0-100 mm); higher is worse	Day 0, Day 8, Month 1, Month 6 , Month 12
Secondary	Severity	Clinical Venous Severity Score (CVSS); score between 0 to 30; higher is worse	Day 0, Day 8, Month 1, Month 6 , Month 12
Secondary	Healing	Time to ulcer healing	Between surgery and 12 months after
Secondary	Ulcer duration	Time without ulcer; time to recurrence (in days )	Between surgery and 12 months after
Secondary	Ulcer recurrence	Rate of recurrence	Between surgery and 12 months after
Secondary	Symptoms	VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire	Day 0, Day 8, Month 1, Month 6 , Month 12
Secondary	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
Secondary	Adverse events	Adverse events related to glue or to the endovenous intervention	Day 0, Day 8, Month 1, Month 6 , Month 12