Status:
COMPLETED
Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue (ETUVVE)
Lead Sponsor:
Clinique Pasteur
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 origi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04714749
Start Date
January 21 2021
End Date
January 30 2024
Last Update
February 8 2024
Active Locations (1)
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1
Clinique Pasteur Toulouse
Toulouse, France, 31076