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

November 1, 2021 updated by: Boston Scientific Corporation

Observational Study of the Effect of VarIthena® on Wound Healing in the Treatment of Venous Leg Ulcers Resulting From Chronic Venous Insufficiency

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6J7S2
        • Oakville Vascular
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Sacramento, California, United States, 95817
        • University of California Davis Health
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • The Vascular Experts
    • Florida
      • Aventura, Florida, United States, 33180
        • Pines Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30306
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60625
        • Swedish Covenant Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass General, Boston
    • New York
      • Buffalo, New York, United States, 14226
        • The Venous Institute of Buffalo
    • Ohio
      • Cincinnati, Ohio, United States, 45211
        • Mercy Health Cincinnati -West Hospital
      • Columbus, Ohio, United States, 43214
        • OhioHealth Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Totality
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Sciences Center at Houston
    • Washington
      • Bellevue, Washington, United States, 98004
        • Lake Washington Vascular, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Wound Perimeter
Time Frame: Baseline to 12 weeks and to 12 months
Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound.
Baseline to 12 weeks and to 12 months
Number of Wound Closure at 12 Weeks
Time Frame: Baseline to 12 weeks
Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.
Baseline to 12 weeks
Time to Wound Closure
Time Frame: Baseline to wound closure or to 12 months, whichever occurs first
Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.
Baseline to wound closure or to 12 months, whichever occurs first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: Baseline to 12 weeks and to 12 months
Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "10". Higher scores mean a worse outcome.
Baseline to 12 weeks and to 12 months
Change on EQ-5D-5L Quality of Life Assessment
Time Frame: Baseline to 12 weeks and to 12 months
Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "1". Higher score mean better outcome.
Baseline to 12 weeks and to 12 months
Change in VCSS
Time Frame: Baseline to 12 weeks and to 12 months
Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of "0" and maximum score of "3". The individual items are added together to assess change from baseline. Higher scores mean worst outcome.
Baseline to 12 weeks and to 12 months
Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date
Time Frame: Baseline to 12 months
Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.
Baseline to 12 months
Number of Wound Recurrences
Time Frame: Baseline to 12 months
Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.
Baseline to 12 months
Number of Ulcer Free Days
Time Frame: Baseline to 12 months
Mean number of ulcer free days defined as days from baseline to date of recurrence
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Shao, MD, Swedish Covenant Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTG-001652-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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