Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

Venous Leg Ulcer GSV AASV Vein Venous Ulcer Varicose Vein VLU venous insufficiency venous disease chronic VLU Varicose Ulcer Leg Ulcer Polidocanol Varithena

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Locations

  • University of California Davis Health
    Sacramento California 95817 United States
  • Stanford University
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Provensis Ltd
Links
Sign up for this study
ID
NCT03257254
Study Type
Observational [Patient Registry]
Last Updated