NCT04714749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

March 6, 2026

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

January 13, 2021

Last Update Submit

March 5, 2026

Conditions

Venous Leg Ulcer

Keywords

endovenous treatmentglue

Outcome Measures

Primary Outcomes (1)

  • Ulcer healing

    Proportion of patients who presented with healing of the venous ulcer

    Between surgery and 12 months after

Secondary Outcomes (9)

  • 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

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Endovenous treatment

EXPERIMENTAL

Endovenous treatment with cyanoacrylate glue

Procedure: Endovenous treatmentDevice: Cyanoacrylate glue

Interventions

Endovenous treatmentPROCEDURE

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

Endovenous treatment
Cyanoacrylate glueDEVICE

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

Endovenous treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Pasteur Toulouse

Toulouse, 31076, France

Location

Related Publications (10)

  • Gohel MS, Barwell JR, Taylor M, Chant T, Foy C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ. 2007 Jul 14;335(7610):83. doi: 10.1136/bmj.39216.542442.BE. Epub 2007 Jun 1.

    PMID: 17545185BACKGROUND

  • Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.

    PMID: 29688123BACKGROUND

  • Hirsch T. Varicose vein therapy and nerve lesions. Vasa. 2017 Mar;46(2):96-100. doi: 10.1024/0301-1526/a000588. Epub 2016 Dec 16.

    PMID: 27981883BACKGROUND

  • Toonder IM, Lam YL, Lawson J, Wittens CH. Cyanoacrylate adhesive perforator embolization (CAPE) of incompetent perforating veins of the leg, a feasibility study. Phlebology. 2014 May;29(1 suppl):49-54. doi: 10.1177/0268355514529696. Epub 2014 May 19.

    PMID: 24843086BACKGROUND

  • Morrison N, Gibson K, Vasquez M, Weiss R, Jones A. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):978-989. doi: 10.1016/j.jvsv.2019.12.080. Epub 2020 Mar 20.

    PMID: 32205125BACKGROUND

  • Heatley F, Onida S, Davies AH. The global management of leg ulceration: Pre early venous reflux ablation trial. Phlebology. 2020 Sep;35(8):576-582. doi: 10.1177/0268355520917847. Epub 2020 Apr 8.

    PMID: 32268842BACKGROUND

  • Abenhaim L, Kurz X. The VEINES study (VEnous Insufficiency Epidemiologic and Economic Study): an international cohort study on chronic venous disorders of the leg. VEINES Group. Angiology. 1997 Jan;48(1):59-66. doi: 10.1177/000331979704800110.

    PMID: 8995345BACKGROUND

  • Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg. 2003 Feb;37(2):410-9. doi: 10.1067/mva.2003.152.

    PMID: 12563215BACKGROUND

  • Kahn SR, Lamping DL, Ducruet T, Arsenault L, Miron MJ, Roussin A, Desmarais S, Joyal F, Kassis J, Solymoss S, Desjardins L, Johri M, Shrier I; VETO Study investigators. VEINES-QOL/Sym questionnaire was a reliable and valid disease-specific quality of life measure for deep venous thrombosis. J Clin Epidemiol. 2006 Oct;59(10):1049-56. doi: 10.1016/j.jclinepi.2005.10.016. Epub 2006 Jun 23.

    PMID: 16980144BACKGROUND

  • Bland JM, Dumville JC, Ashby RL, Gabe R, Stubbs N, Adderley U, Kang'ombe AR, Cullum NA. Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial. BMC Cardiovasc Disord. 2015 Aug 11;15:85. doi: 10.1186/s12872-015-0080-7.

    PMID: 26260973BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nicolas NEAUME, MD

    Clinique Pasteur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 19, 2021

Study Start

January 21, 2021

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

March 6, 2026

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)