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

Clinique Pasteur

Status

Completed

Conditions

Venous Leg Ulcer

Treatments

Procedure: Endovenous treatment

Device: Cyanoacrylate glue

Study type

Interventional

Funder types

Other

Identifiers

NCT04714749

2020-A02799-30

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No 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