Finnish Venous Ulcer Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 5
- 主要终点
- Time to ulcer Healing
研究概览
简要总结
This multicenter randomized controlled trial evaluates the effect of first-visit foam sclerotherapy (including sub-ulcer foam sclerotherapy) in patients with venous leg ulcer.
详细描述
To evaluate the effect of first-visit foam sclerotherapy, patients with venous leg ulcers are randomly assigned to either the first-visit foam sclerotherapy group or the scheduled treatment group. The scheduled treatment group represents the current standard of care. The primary outcome of this study is the time to ulcer healing.
In addition to the first-visit treatment in the study group, both groups receive endothermal ablation and/or foam sclerotherapy to (further) treat ulcer-related insufficient veins and truncal insufficiency in scheduled treatment visit(s).
Class 2 thigh-high compression or the best possible compression therapy tolerated by the patient is provided in both groups. The follow-up period for the primary outcome is one year.
For this study, based on Oulu University Hospital's retrospective data (partly published in Pihlaja et al 2020) of venous ulcer healing the investigators assumed Hazard Ratio 1.5 for venous ulcer to heal in first-visit foam sclerotherapy group compared to scheduled treatment group.
Assuming drop-out of 10% this study recruits total of 248 patients (a=0.05, b=0.2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient informed consent
- •Venous ulcer, aged from one month to one year
- •Duplex ultrasonography verified (vein reflux greater than >0.5 second) superficial venous insufficiency
- •Sufficient arterial circulation (at least on criterion met: Palpable distal pulses / ankle-brachial index > 0,8 / Toe pressure >60mmhg)
排除标准
- •Leg ulcers other than venous etiology
- •Ulcers requiring operation theater revision
- •Patent foramen ovale
- •Several times recurrent (over 3 recurrences) venous ulcer
- •Body Mass Index over 40
- •Pregnancy
结局指标
主要结局
Time to ulcer Healing
时间窗: 0-365 days
Complete re-epithelialisation of ulcer area
次要结局
- EQ-5D Questionnaire(0-365 days)
- Venous ulcer area(0-365 days)
- Wound-QOL Questionnaire(0-365 days)
研究者
Toni Pihlaja
Principal Investigator
Oulu University Hospital