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

Primary Purpose

Venous Leg Ulcer

Status

Active

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Endovenous treatment

Cyanoacrylate glue

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring endovenous treatment, glue

Eligibility Criteria

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

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

Sites / Locations

Clinique Pasteur Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovenous treatment

Arm Description

Endovenous treatment with cyanoacrylate glue

Outcomes

Primary Outcome Measures

Ulcer healing

Proportion of patients who presented with healing of the venous ulcer

Secondary Outcome Measures

Functional and technical success

Success assessed by occlusion of treated veins

VAS Pain

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

Severity

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

Healing

Time to ulcer healing

Ulcer duration

Time without ulcer; time to recurrence (in days )

Ulcer recurrence

Rate of recurrence

Symptoms

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

Patient Quality of Life

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

Adverse events

Adverse events related to glue or to the endovenous intervention

Full Information

NCT ID

NCT04714749

First Posted

January 13, 2021

Last Updated

February 20, 2023

Sponsor

Clinique Pasteur

1. Study Identification

Unique Protocol Identification Number

NCT04714749

Brief Title

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

Acronym

ETUVVE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 21, 2021 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Clinique Pasteur

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

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.

6. Conditions and Keywords

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

Venous Leg Ulcer

Keywords

endovenous treatment, glue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endovenous treatment

Arm Type

Experimental

Arm Description

Endovenous treatment with cyanoacrylate glue

Intervention Type

Procedure

Intervention Name(s)

Endovenous treatment

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Cyanoacrylate glue

Intervention Description

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

Primary Outcome Measure Information:

Title

Ulcer healing

Description

Proportion of patients who presented with healing of the venous ulcer

Time Frame

Between surgery and 12 months after

Secondary Outcome Measure Information:

Title

Functional and technical success

Description

Success assessed by occlusion of treated veins

Time Frame

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

Title

VAS Pain

Description

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

Time Frame

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

Title

Severity

Description

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

Time Frame

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

Title

Healing

Description

Time to ulcer healing

Time Frame

Between surgery and 12 months after

Title

Ulcer duration

Description

Time without ulcer; time to recurrence (in days )

Time Frame

Between surgery and 12 months after

Title

Ulcer recurrence

Description

Rate of recurrence

Time Frame

Between surgery and 12 months after

Title

Symptoms

Description

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

Time Frame

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

Title

Patient Quality of Life

Description

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

Time Frame

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

Title

Adverse events

Description

Adverse events related to glue or to the endovenous intervention

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas NEAUME, MD

Organizational Affiliation

Clinique Pasteur

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinique Pasteur Toulouse

City

Toulouse

ZIP/Postal Code

31076

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17545185

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.

Results Reference

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PubMed Identifier

29688123

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.

Results Reference

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PubMed Identifier

27981883

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.

Results Reference

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PubMed Identifier

24843086

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.

Results Reference

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PubMed Identifier

32205125

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.

Results Reference

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PubMed Identifier

32268842

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.

Results Reference

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PubMed Identifier

8995345

Citation

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.

Results Reference

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PubMed Identifier

12563215

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.

Results Reference

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PubMed Identifier

16980144

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.

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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.

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

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