An interventional study of Endovenous treatment and Cyanoacrylate glue in Venous Leg Ulcer, sponsored by Clinique Pasteur. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Clinique Pasteur · Not applicable, Interventional, and Treatment
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.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 309 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Clinique Pasteur is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endovenous treatment with cyanoacrylate glue
Procedure: Endovenous treatment · Device: Cyanoacrylate glue
Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue
Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue
Ulcer healing
Proportion of patients who presented with healing of the venous ulcer
Time frame: Between surgery and 12 months after
Functional and technical success
Success assessed by occlusion of treated veins
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
VAS Pain
Visual analogue scale (0-100 mm); higher is worse
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
Severity
Clinical Venous Severity Score (CVSS); score between 0 to 30; higher is worse
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
Healing
Time to ulcer healing
Time frame: Between surgery and 12 months after
Ulcer duration
Time without ulcer; time to recurrence (in days )
Time frame: Between surgery and 12 months after
Ulcer recurrence
Rate of recurrence
Time frame: Between surgery and 12 months after
Symptoms
VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire
Time frame: 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
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
Adverse events
Adverse events related to glue or to the endovenous intervention
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
Plan to share: No
Ran from Jan 2021 to primary completion in Jan 2024, 36 months.
Of 67 non-industry interventional studies with no phase under Varicose Ulcer, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 65. This study's 36 months is close to that.
Counting every sponsor, half of 133 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Clinique Pasteur