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

Study Overview
=================
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.

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

Conditions
-----------------
Venous Leg Ulcer

Intervention / Treatment
-----------------
* Procedure: Endovenous treatment
* Device: Cyanoacrylate glue


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endovenous treatment, glue