Clinical trial NCT04714749: Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue (ETUVVE)
Official title: Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: endovenous treatment
glue
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ulcer healing
timeFrame: Between surgery and 12 months after
Secondary outcomes:
measure: Functional and technical success
timeFrame: Day 0, Day 8, Month 1, Month 6 , Month 12
measure: VAS Pain
timeFrame: Day 0, Day 8, Month 1, Month 6 , Month 12
measure: Severity
timeFrame: Day 0, Day 8, Month 1, Month 6 , Month 12
measure: Healing
timeFrame: Between surgery and 12 months after
measure: Ulcer duration
timeFrame: Between surgery and 12 months after
measure: Ulcer recurrence
timeFrame: Between surgery and 12 months after
measure: Symptoms
timeFrame: Day 0, Day 8, Month 1, Month 6 , Month 12
measure: Patient Quality of Life
timeFrame: Day 0, Day 8, Month 1, Month 6 , Month 12
measure: Adverse events
timeFrame: Day 0, Day 8, Month 1, Month 6 , Month 12
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
Study officials:
affiliation: Clinique Pasteur
name: Nicolas NEAUME, MD
role: PRINCIPAL_INVESTIGATOR
References:
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