Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Clinique Pasteur
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Ulcer healing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Endovenous treatment
Endovenous treatment with cyanoacrylate glue
Intervention: Endovenous treatment (Procedure)
Endovenous treatment
Endovenous treatment with cyanoacrylate glue
Intervention: Cyanoacrylate glue (Device)
Outcomes
Primary Outcomes
Ulcer healing
Time Frame: Between surgery and 12 months after
Proportion of patients who presented with healing of the venous ulcer
Secondary Outcomes
- Functional and technical success(Day 0, Day 8, Month 1, Month 6 , Month 12)
- VAS Pain(Day 0, Day 8, Month 1, Month 6 , Month 12)
- Patient Quality of Life(Day 0, Day 8, Month 1, Month 6 , Month 12)
- Severity(Day 0, Day 8, Month 1, Month 6 , Month 12)
- Healing(Between surgery and 12 months after)
- Ulcer duration(Between surgery and 12 months after)
- Ulcer recurrence(Between surgery and 12 months after)
- Symptoms(Day 0, Day 8, Month 1, Month 6 , Month 12)
- Adverse events(Day 0, Day 8, Month 1, Month 6 , Month 12)
Investigators
Nicolas NEAUME
Principal investigator, MD
Clinique Pasteur