Observational Study of the Effect of VarIthena® on Wound Healing in the Treatment of Venous Leg Ulcers Resulting From Chronic Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 14
- 主要终点
- Change From Baseline in Wound Perimeter
研究概览
简要总结
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change From Baseline in Wound Perimeter
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date(Baseline to 12 months)
- Change in VCSS(Baseline to 12 weeks and to 12 months)
- Change in Pain(Baseline to 12 weeks and to 12 months)
- Change on EQ-5D-5L Quality of Life Assessment(Baseline to 12 weeks and to 12 months)
- Number of Wound Recurrences(Baseline to 12 months)
- Number of Ulcer Free Days(Baseline to 12 months)