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

NCT04714749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Venous Leg Ulcer

Interventions

PROCEDURE

Endovenous treatment

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

DEVICE

Cyanoacrylate glue

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

Sponsors & Collaborators

  • Clinique Pasteur

    lead OTHER

Principal Investigators

  • Nicolas NEAUME, MD · Clinique Pasteur

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2024-01-30
Completion
2024-01-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714749 on ClinicalTrials.gov