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

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

Detailed Description
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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.

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

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Drug: Varithena


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Varithena|Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Wound Perimeter | 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. | Baseline to 12 weeks and to 12 months | 
| Number of Wound Closure at 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. | Baseline to 12 weeks | 
| Time to Wound Closure | Median number of days to wound closure measured weekly. Wound closure as measured by photograph inputted into wound measuring technology platform. | Baseline to wound closure or to 12 months, whichever occurs first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | 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. | Baseline to 12 weeks and to 12 months | 
| Change on EQ-5D-5L Quality of Life Assessment | 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. | Baseline to 12 weeks and to 12 months | 
| Change in VCSS | 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. | Baseline to 12 weeks and to 12 months | 
| Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date | Count of wounds remaining closed at 3 months post-wound closure determined via photograph and assessed by wound measurement technology platform. | Baseline to 12 months | 
| Number of Wound Recurrences | Count of wound recurrences of healed wounds. For healed wounds, VLU recurrence was collected via phone calls and subjects at follow up timelines. | Baseline to 12 months | 
| Number of Ulcer Free Days | Mean number of ulcer free days defined as days from baseline to date of recurrence | Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSV, AASV, Vein, Venous, Ulcer, Varicose Vein, VLU, venous insufficiency, venous disease, chronic VLU