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Completed

NCT Number: NCT03257254

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

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

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ulcer Varicose Ulcer Varicose Veins Vascular Diseases Venous Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oakville Vascular, Oakville, Ontario, Canada

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varithena

Drug

Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.

Primary outcomes

  1. Change From Baseline in Wound Perimeter

    Time frame: 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.

  2. Number of Wound Closure at 12 Weeks

    Time frame: 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.

  3. Time to Wound Closure

    Time frame: 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 outcomes

  1. Change in Pain

    Time frame: 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.

  2. Change on EQ-5D-5L Quality of Life Assessment

    Time frame: 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.

  3. Change in VCSS

    Time frame: 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.

  4. Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date

    Time frame: 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.

  5. Number of Wound Recurrences

    Time frame: 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.

  6. Number of Ulcer Free Days

    Time frame: Baseline to 12 months

    Mean number of ulcer free days defined as days from baseline to date of recurrence

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: VIEW-VLU

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2017
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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