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

Venous Leg Ulcer Clinical Trial

— VIEW-VLU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257254
• Other study ID #: BTG-001652-01
• Status: Completed
• Start date: September 29, 2017
• Est. completion date: September 28, 2020

Study information

• Verified date: November 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 28, 2020
• Est. primary completion date: May 18, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Insufficiency
• Venous Leg Ulcer

Intervention

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

Locations

Country	Name	City	State
Canada	Oakville Vascular	Oakville	Ontario
United States	Emory University Hospital	Atlanta	Georgia
United States	Pines Clinical Research	Aventura	Florida
United States	Lake Washington Vascular, PLLC	Bellevue	Washington
United States	Mass General, Boston	Boston	Massachusetts
United States	The Venous Institute of Buffalo	Buffalo	New York
United States	Swedish Covenant Hospital	Chicago	Illinois
United States	Mercy Health Cincinnati -West Hospital	Cincinnati	Ohio
United States	OhioHealth Research	Columbus	Ohio
United States	The Vascular Experts	Darien	Connecticut
United States	University of Texas Health Sciences Center at Houston	Houston	Texas
United States	Totality	Oklahoma City	Oklahoma
United States	Stanford University	Palo Alto	California
United States	University of California Davis Health	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in Pain	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
Secondary	Change on EQ-5D-5L Quality of Life Assessment	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
Secondary	Change in VCSS	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
Secondary	Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date	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
Secondary	Number of Wound Recurrences	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
Secondary	Number of Ulcer Free Days	Mean number of ulcer free days defined as days from baseline to date of recurrence	Baseline to 12 months