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Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)

NCT ID: NCT03257254

Last Updated: 2021-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-29

Study Completion Date

2020-09-28

Brief Summary

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A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.

Detailed Description

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This 12 month, multicenter, open-label registry is designed to collect treatment and outcome data related to participants treated with Varithena for great saphenous vein (GSV) system and/or anterior accessory saphenous vein (AASV) incompetence resulting in VLU. Participant are treated per Investigator's Standard of Care (SoC) and in accordance with the Full Prescribing Information (FPI) and Instructions for Use (IFU). For participants with healed ulcers during the 12 month follow-up period, VLU recurrence information is collected.

Conditions

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Venous Leg Ulcer

Keywords

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GSV AASV Vein Venous Ulcer Varicose Vein VLU venous insufficiency venous disease chronic VLU

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Varithena

Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women; age ≥18
* Investigator has selected Varithena® to treat participants classified C6 with chronic (≥3 months) VLU resulting from GSV and/or AASV incompetence
* Wound can be visualized in one plane to allow for image collection of the entire wound in one photograph, or if wound is circumferential, participant must be able to capture the entire wound using multiple photographs taken from directly above the wound (straight on)
* Reflux \>500 milliseconds (ms) on duplex ultrasound
* Willing and able to collect wound photographs and data using an application installed on a tablet
* Willing and able to return for scheduled follow-up and wound care visits
* Ability to comprehend and sign informed consent form (ICF) and complete questionnaires

Exclusion Criteria

* Contraindications to Varithena® 1% in accordance with the FPI
* Any serious concomitant disease, per physician's discretion, that confounds wound healing, including malignant changes of wound
* Concomitant heat ablation, or heat ablation of index leg within 6 weeks prior to treatment with Varithena®
* Significant arterial disease or ankle-brachial pressure index (ABPI) ≤0.8
* In the opinion of Investigator, wound would close within 12 weeks without additional treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Shao, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Covenant Hospital

Locations

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Stanford University

Palo Alto, California, United States

Site Status

University of California Davis Health

Sacramento, California, United States

Site Status

The Vascular Experts

Darien, Connecticut, United States

Site Status

Pines Clinical Research

Aventura, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Swedish Covenant Hospital

Chicago, Illinois, United States

Site Status

Mass General, Boston

Boston, Massachusetts, United States

Site Status

The Venous Institute of Buffalo

Buffalo, New York, United States

Site Status

Mercy Health Cincinnati -West Hospital

Cincinnati, Ohio, United States

Site Status

OhioHealth Research

Columbus, Ohio, United States

Site Status

Totality

Oklahoma City, Oklahoma, United States

Site Status

University of Texas Health Sciences Center at Houston

Houston, Texas, United States

Site Status

Lake Washington Vascular, PLLC

Bellevue, Washington, United States

Site Status

Oakville Vascular

Oakville, Ontario, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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BTG-001652-01

Identifier Type: -

Identifier Source: org_study_id