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

NCT03257254 | Completed Results FDA Drug

• 1 other identifier: BTG-001652-01
• Study Type: observational
• Target: 76
• Locations: 2 countries
• Sites: 14

Brief Summary

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

Conditions

Venous Leg Ulcer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Wound Perimeter

  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

  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

  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 Outcomes (6)

• Change in Pain

  Baseline to 12 weeks and to 12 months

• Change on EQ-5D-5L Quality of Life Assessment

  Baseline to 12 weeks and to 12 months

• Change in VCSS

  Baseline to 12 weeks and to 12 months

• Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date

  Baseline to 12 months

• Number of Wound Recurrences

  Baseline to 12 months

Interventions

Varithena DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (14)

Stanford University

Palo Alto, California, 94304, United States

Location

University of California Davis Health

Sacramento, California, 95817, United States

Location

The Vascular Experts

Darien, Connecticut, 06820, United States

Location

Pines Clinical Research

Aventura, Florida, 33180, United States

Location

Emory University Hospital

Atlanta, Georgia, 30306, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

Mass General, Boston

Boston, Massachusetts, 02114, United States

Location

The Venous Institute of Buffalo

Buffalo, New York, 14226, United States

Location

Mercy Health Cincinnati -West Hospital

Cincinnati, Ohio, 45211, United States

Location

OhioHealth Research

Columbus, Ohio, 43214, United States

Location

Totality

Oklahoma City, Oklahoma, 73118, United States

Location

University of Texas Health Sciences Center at Houston

Houston, Texas, 77030, United States

Location

Lake Washington Vascular, PLLC

Bellevue, Washington, 98004, United States

Location

Oakville Vascular

Oakville, Ontario, L6J7S2, Canada

Location

MeSH Terms

Conditions

Varicose Ulcer; Ulcer; Varicose Veins; Venous Insufficiency

Interventions

Polidocanol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Timothy Keo
• Organization: Boston Scientific

Timothy.Keo@bsci.com

425-599-3814

Study Officials

• Michael Shao, MD

  Swedish Covenant Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: September 29, 2017
• Primary Completion: May 18, 2020
• Study Completion: September 28, 2020
• Last Updated: December 14, 2021
• Results First Posted: December 14, 2021

Record last verified: 2021-11

Locations

CA (1); US (13)