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

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ClinicalTrials.gov Identifier: NCT03257254
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Provensis Ltd

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

Condition or disease Intervention/treatment
Venous Leg Ulcer Drug: Varithena

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Observational Study of the Effect of VarIthena® on Wound Healing in the Treatment of Venous Leg Ulcers Resulting From Chronic Venous Insufficiency
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Polidocanol


Intervention Details:
  • Drug: Varithena
    Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.


Primary Outcome Measures :
  1. Epithelial Migration Measured by Change in Perimeter of Wound [ Time Frame: Weekly up to wound closure or 12 months, whichever occurs first ]
    Decrease in wound perimeter per week.

  2. Wound Closure Rate [ Time Frame: at 12 weeks ]
    Number of healed wounds at 12 weeks post treatment.

  3. Time to Wound Closure [ Time Frame: Weekly up to wound closure or 12 months, whichever occurs first ]
    Mean number of weeks to wound closure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257254


Contacts
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Contact: Michael Shao, MD 773-781-6352 MShao@schosp.org
Contact: Sr. Manager Clinical Development, MA 425-415-3186

Locations
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United States, California
San Diego Vascular Center Recruiting
Escondido, California, United States, 92025
Contact: Hope Donovan    858-397-5819    adonovan@milestonecro.com   
The Vein Center at Mission Heritage Medical Recruiting
Mission Viejo, California, United States, 92691
Contact: Emilie Fien       Emilie.Fien@stjoe.org   
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Fouzia Khan    650-736-1410    fouziak@stanford.edu   
University of California Davis Health Recruiting
Sacramento, California, United States, 95817
Contact: Laura Jones       lbjjones@ucdavis.edu   
United States, Connecticut
The Vascular Experts Recruiting
Darien, Connecticut, United States, 06820
Contact: Maria Myslinski    203-956-6834    mmyslinski@thevascularexperts.com   
United States, Florida
Pines Clinical Research Recruiting
Aventura, Florida, United States, 33180
Contact: Jenifer Varon    305-792-0555    pcrjvaron@aol.com   
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30306
Contact: Mary Mungai       Mary.mungai@emoryhealthcare.org   
United States, Illinois
Swedish Covenant Hospital Recruiting
Chicago, Illinois, United States, 60625
Contact: Lauren Krist       lkrist@clintell.com   
United States, Massachusetts
Mass General, Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Tara Bresnahan    617-643-2731    tbresnahan2@mgh.harvard.edu   
United States, New York
The Venous Institute of Buffalo Recruiting
Buffalo, New York, United States, 14226
Contact: Kristina Donaldson    716-877-7000    kristinadonaldson@venousinstitute.com   
United States, Ohio
Mercy Health Cincinnati -West Hospital Recruiting
Cincinnati, Ohio, United States, 45211
Contact: Cendi Kegli    513-952-5104    crkegley@mercy.com   
OhioHealth Research Recruiting
Columbus, Ohio, United States, 43214
Contact: Jodie Carter Ohl    614-788-3866    jodie.carter-ohl@ohiohealth.com   
United States, Oklahoma
Totality Active, not recruiting
Oklahoma City, Oklahoma, United States, 73118
United States, Texas
University of Texas Health Sciences Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Whitley Ausbie       Whitley.E.Ausbie@uth.tmc.edu   
United States, Washington
Lake Washington Vascular, PLLC Recruiting
Bellevue, Washington, United States, 98004
Contact: Kim Glorieux       kimg@lkwv.com   
Canada, Ontario
Oakville Vascular Active, not recruiting
Oakville, Ontario, Canada, L6J7S2
Sponsors and Collaborators
Provensis Ltd
Investigators
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Principal Investigator: Michael Shao, MD Swedish Covenant Hospital

Additional Information:

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Responsible Party: Provensis Ltd
ClinicalTrials.gov Identifier: NCT03257254     History of Changes
Other Study ID Numbers: BTG-001652-01
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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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
Keywords provided by Provensis Ltd:
GSV
AASV
Vein
Venous
Ulcer
Varicose Vein
VLU
venous insufficiency
venous disease
chronic VLU
Additional relevant MeSH terms:
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Varicose Ulcer
Venous Insufficiency
Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions