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Completed

NCT Number: NCT04714749

Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue (ETUVVE)

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Pasteur Toulouse

Toulouse, 31076, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovenous treatment

Procedure

Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue

Cyanoacrylate glue

Device

Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue

Primary outcomes

  1. Ulcer healing

    Time frame: Between surgery and 12 months after

    Proportion of patients who presented with healing of the venous ulcer

Secondary outcomes

  1. Functional and technical success

    Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12

    Success assessed by occlusion of treated veins

  2. VAS Pain

    Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12

    Visual analogue scale (0-100 mm); higher is worse

  3. Severity

    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

  4. Healing

    Time frame: Between surgery and 12 months after

    Time to ulcer healing

  5. Ulcer duration

    Time frame: Between surgery and 12 months after

    Time without ulcer; time to recurrence (in days )

  6. Ulcer recurrence

    Time frame: Between surgery and 12 months after

    Rate of recurrence

  7. Symptoms

    Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12

    VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire

  8. Patient Quality of Life

    Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12

    VEINES QOL (VEnous INsufficiency Epidemiologic and Economic Study- Quality Of Life) Questionnaire

  9. Adverse events

    Time frame: Day 0, Day 8, Month 1, Month 6 , Month 12

    Adverse events related to glue or to the endovenous intervention

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Registry information

Official study title

Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue

Acronym: ETUVVE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2021
Registry last updated
Jun 16, 2026

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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