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

Completed

Brief 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Wound Perimeter	Baseline to 12 weeks and to 12 months	Mean change in wound perimeter as measured by photograph inputted into wound measuring technology platform. Larger number indicates a lower wound perimeter compared to baseline. Epithelial migration measured by change in perimeter of wound.
Number of Wound Closure at 12 Weeks	Baseline to 12 weeks	Total number of healed wounds at 12 weeks post treatment. Wound healing is measured measured by photograph inputted into wound measuring technology platform.
Time to Wound Closure	Baseline to wound closure or to 12 months, whichever occurs first	Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform.

Secondary Outcome Measures

Name	Time	Method
Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date	Baseline to 12 months	Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform.
Change in VCSS	Baseline to 12 weeks and to 12 months	Mean change in Venous Clinical Severity Score (VCSS) from baseline to 12 month follow up. VCSS assesses nine common signs/symptoms of venous disease and each item is scored individually with a minimum score of "0" and maximum score of "3". The individual items are added together to assess change from baseline. Higher scores mean worst outcome.
Change in Pain	Baseline to 12 weeks and to 12 months	Mean change in pain on numeric pain rating scale (NPRS) compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "10". Higher scores mean a worse outcome.
Change on EQ-5D-5L Quality of Life Assessment	Baseline to 12 weeks and to 12 months	Mean change on 5-level EQ-5D (EQ-5D-5L) quality of life assessment compared to baseline at 12 months post-treatment. Minimum value is "0" and maximum value is "1". Higher score mean better outcome.
Number of Wound Recurrences	Baseline to 12 months	Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines.
Number of Ulcer Free Days	Baseline to 12 months	Mean number of ulcer free days defined as days from baseline to date of recurrence

Locations (14): Pines Clinical Research
🇺🇸
Aventura, Florida, United States
Oakville Vascular
🇨🇦
Oakville, Ontario, Canada
OhioHealth Research
🇺🇸
Columbus, Ohio, United States
Totality
🇺🇸
Oklahoma City, Oklahoma, United States
Swedish Covenant Hospital
🇺🇸
Chicago, Illinois, United States
Mercy Health Cincinnati -West Hospital
🇺🇸
Cincinnati, Ohio, United States
Mass General, Boston
🇺🇸
Boston, Massachusetts, United States
Stanford University
🇺🇸
Palo Alto, California, United States
The Vascular Experts
🇺🇸
Darien, Connecticut, United States
University of Texas Health Sciences Center at Houston
🇺🇸
Houston, Texas, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
University of California Davis Health
🇺🇸
Sacramento, California, United States
The Venous Institute of Buffalo
🇺🇸
Buffalo, New York, United States
Lake Washington Vascular, PLLC
🇺🇸
Bellevue, Washington, United States