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

Completed

Conditions studied: Venous Leg Ulcer

In brief

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

Key facts

Study ID

NCT03257254

Run by

Boston Scientific Corporation

People needed

76

Starts

2017-09-29

Expected to finish

2020-09-28

Last updated by the study team

2021-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.