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

Boston Scientific Corporation76 enrolled

Overview

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

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

OBSERVATIONAL

Enrollment

Conditions

Venous Leg Ulcer

Interventions

VarithenaDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Stanford University

Palo Alto, California, United States

University of California Davis Health

Sacramento, California, United States

The Vascular Experts

Darien, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to wound closure or to 12 months, whichever occurs first

Secondary Outcomes

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.

Time frame: Baseline to 12 weeks and to 12 months

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.

Time frame: Baseline to 12 weeks and to 12 months

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.

Data from ClinicalTrials.gov

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