Venous Leg Ulcer
Conditions
Keywords
endovenous treatment, glue
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 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.
Interventions
PROCEDUREEndovenous treatment
Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue
DEVICECyanoacrylate glue
Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue
Sponsors
Clinique Pasteur
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer healing | Between surgery and 12 months after | Proportion of patients who presented with healing of the venous ulcer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional and technical success | Day 0, Day 8, Month 1, Month 6 , Month 12 | Success assessed by occlusion of treated veins |
| VAS Pain | Day 0, Day 8, Month 1, Month 6 , Month 12 | Visual analogue scale (0-100 mm); higher is worse |
| Severity | Day 0, Day 8, Month 1, Month 6 , Month 12 | Clinical Venous Severity Score (CVSS); score between 0 to 30; higher is worse |
| Healing | Between surgery and 12 months after | Time to ulcer healing |
| Ulcer duration | Between surgery and 12 months after | Time without ulcer; time to recurrence (in days ) |
| Ulcer recurrence | Between surgery and 12 months after | Rate of recurrence |
| Symptoms | Day 0, Day 8, Month 1, Month 6 , Month 12 | VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire |
| Patient Quality of Life | Day 0, Day 8, Month 1, Month 6 , Month 12 | VEINES QOL (VEnous INsufficiency Epidemiologic and Economic Study- Quality Of Life) Questionnaire |
| Adverse events | Day 0, Day 8, Month 1, Month 6 , Month 12 | Adverse events related to glue or to the endovenous intervention |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORNicolas NEAUME, MD
Clinique Pasteur
Outcome results
None listed