Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

University of Texas Health Sciences Center at Houston
Houston, Texas 77030
Contact:
Whitley Ausbie
Whitley.E.Ausbie@uth.tmc.edu

More Details

NCT ID
NCT03257254
Status
Recruiting
Sponsor
Provensis Ltd

Study Contact

Michael Shao, MD
773-781-6352
MShao@schosp.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.