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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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
Clinique Pasteur Toulouse
Toulouse, France
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
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