NCT03257254

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DRUG	Varithena	Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.

Timeline

• Start date: 2017-09-29
• Primary completion: 2020-05-18
• Completion: 2020-09-28
• First posted: 2017-08-22
• Last updated: 2021-12-14
• Results posted: 2021-12-14

Locations

14 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study