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Cyanoacrylate Closure for Treatment of Venous Leg Ulcers

NCT04011371 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-04-13

No results posted yet for this study

Summary

Venous leg ulcers (VLUs) are a common wound with significant morbidity and cost, and suboptimal therapeutic options. VLUs result from chronic venous insufficiency, including venous reflux and post-thrombotic syndrome. VLU can take from months to years to heal, and 54-78% recur. Current therapies include wound, compression therapy, and medications. These treatments can increase the rate of healing, and reduce recurrence, however these therapies can be burdensome, painful, and ineffective, and despite these therapies, \~50% of wounds become chronic. Chronic VLUs can be painful, malodorous, and infected, and they often significantly limit an individual's function and mobility. An emerging therapy for symptomatic venous reflux is the closure of the culprit vein by endovenous closure with a cyanoacrylate adhesive implant. Recent studies show cyanoacrylate closure (CAC) to be a safe and effective treatment for varicosities resulting from symptomatic incompetent great saphenous veins. This study will evaluate the safety and effectiveness of CAC for VLUs.

Conditions

  • Venous Leg Ulcer

Interventions

PROCEDURE

Cyanoacrylate closure

Cyanoacrylate glue embolization targeting venous insufficiency

Sponsors & Collaborators

  • Medtronic Vascular

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-06-01
Completion
2022-06-01

Countries

  • Canada

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 NCT04011371 on ClinicalTrials.gov