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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovenous treatment | Experimental | Endovenous treatment with cyanoacrylate glue |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovenous treatment | Procedure | Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer healing | Proportion of patients who presented with healing of the venous ulcer | Between surgery and 12 months after |
| Measure | Description | Time Frame |
|---|---|---|
| Functional and technical success | Success assessed by occlusion of treated veins | Day 0, Day 8, Month 1, Month 6 , Month 12 |
| VAS Pain | Visual analogue scale (0-100 mm); higher is worse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas NEAUME, MD | Clinique Pasteur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pasteur Toulouse | Toulouse | 31076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17545185 | Background | 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. | |
| 29688123 |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Cyanoacrylate glue | Device | Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue |
|
| Day 0, Day 8, Month 1, Month 6 , Month 12 |
| Severity | Clinical Venous Severity Score (CVSS); score between 0 to 30; higher is worse | Day 0, Day 8, Month 1, Month 6 , Month 12 |
| Healing | Time to ulcer healing | Between surgery and 12 months after |
| Ulcer duration | Time without ulcer; time to recurrence (in days ) | Between surgery and 12 months after |
| Ulcer recurrence | Rate of recurrence | Between surgery and 12 months after |
| Symptoms | VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire | Day 0, Day 8, Month 1, Month 6 , Month 12 |
| Patient Quality of Life | VEINES QOL (VEnous INsufficiency Epidemiologic and Economic Study- Quality Of Life) Questionnaire | Day 0, Day 8, Month 1, Month 6 , Month 12 |
| Adverse events | Adverse events related to glue or to the endovenous intervention | Day 0, Day 8, Month 1, Month 6 , Month 12 |
| 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. |
| 27981883 | Background | 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. |
| 24843086 | Background | 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. |
| 32205125 | Background | 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. |
| 32268842 | Background | 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. |
| 8995345 | Background | 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. |
| 12563215 | Background | 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. |
| 16980144 | Background | 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. |
| 26260973 | Background | 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. |
| Result | Nicolas Néaume, Fannie Forgues, Laurence Allouche, Sarah Bruni, Karol Chakkour, Clélia Dornier-Cassagneau, Philippe Léger, Nicolas Savy, Nicolas Mayeur, Treatment of venous leg ulcers by cyanoacrylate glue: A prospective study of safety and feasibility, JVS-Vascular Insights, Volume 4, 2026, 100393, ISSN 2949-9127, https://doi.org/10.1016/j.jvsvi.2026.100393. |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |