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

Not Applicable

Completed

• Conditions: Venous Leg Ulcer
• Interventions: Procedure: Endovenous treatment; Device: Cyanoacrylate glue

• Registration Number: NCT04714749
• Lead Sponsor: Clinique Pasteur

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-19
• Study Start: 2021-01-21
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovenous treatment	Endovenous treatment	Endovenous treatment with cyanoacrylate glue
Endovenous treatment	Cyanoacrylate glue	Endovenous treatment with cyanoacrylate glue

Primary Outcome Measures

Name	Time	Method
Ulcer healing	Between surgery and 12 months after	Proportion of patients who presented with healing of the venous ulcer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique Pasteur Toulouse; 🇫🇷 Toulouse, France