Clinical trial NCT03257254: Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
Official title: Observational Study of the Effect of VarIthena® on Wound Healing in the Treatment of Venous Leg Ulcers Resulting From Chronic Venous Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Leg Ulcer
Keywords: GSV
AASV
Vein
Venous
Ulcer
Varicose Vein
VLU
venous insufficiency
venous disease
chronic VLU
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants classified C6 on Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification with active VLU resulting from venous insufficiency of the GSV system and/or AASV

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.

Eligibility criteria: 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 outcomes:
measure: Change From Baseline in Wound Perimeter
timeFrame: Baseline to 12 weeks and to 12 months
measure: Number of Wound Closure at 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Time to Wound Closure
timeFrame: Baseline to wound closure or to 12 months, whichever occurs first
Secondary outcomes:
measure: Change in Pain
timeFrame: Baseline to 12 weeks and to 12 months
measure: Change on EQ-5D-5L Quality of Life Assessment
timeFrame: Baseline to 12 weeks and to 12 months
measure: Change in VCSS
timeFrame: Baseline to 12 weeks and to 12 months
measure: Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date
timeFrame: Baseline to 12 months
measure: Number of Wound Recurrences
timeFrame: Baseline to 12 months
measure: Number of Ulcer Free Days
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
city: Darien
country: United States
facility: The Vascular Experts
state: Connecticut
city: Aventura
country: United States
facility: Pines Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Swedish Covenant Hospital
state: Illinois
city: Boston
country: United States
facility: Mass General, Boston
state: Massachusetts
city: Buffalo
country: United States
facility: The Venous Institute of Buffalo
state: New York
city: Cincinnati
country: United States
facility: Mercy Health Cincinnati -West Hospital
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research
state: Ohio
city: Oklahoma City
country: United States
facility: Totality
state: Oklahoma
city: Houston
country: United States
facility: University of Texas Health Sciences Center at Houston
state: Texas
city: Bellevue
country: United States
facility: Lake Washington Vascular, PLLC
state: Washington
city: Oakville
country: Canada
facility: Oakville Vascular
state: Ontario
Study officials:
affiliation: Swedish Covenant Hospital
name: Michael Shao, MD
role: PRINCIPAL_INVESTIGATOR
References: