Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue (ETUVVE) (NCT04714749) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue (ETUVVE)
France38 participantsStarted 2021-01-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dista…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.