Clinique Pasteur Toulouse
Toulouse, 31076, France
NCT Number: NCT04714749
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Toulouse, 31076, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Between surgery and 12 months after
Proportion of patients who presented with healing of the venous ulcer
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
Success assessed by occlusion of treated veins
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
Visual analogue scale (0-100 mm); higher is worse
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
Clinical Venous Severity Score (CVSS); score between 0 to 30; higher is worse
Time frame: Between surgery and 12 months after
Time to ulcer healing
Time frame: Between surgery and 12 months after
Time without ulcer; time to recurrence (in days )
Time frame: Between surgery and 12 months after
Rate of recurrence
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire
Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12
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 related to glue or to the endovenous intervention
Clinique Pasteur
Other
Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue
Acronym: ETUVVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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