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

Boston Scientific

Status: Completed

Conditions: Venous Leg Ulcer

Treatments: Drug: Varithena

Study type: Observational

Funder types: Industry

Identifiers

NCT03257254

BTG-001652-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design