NCT01673412已完成不适用
Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 70
- 主要终点
- Healing or non-healing of venous leg ulcers at week 24
研究概览
简要总结
This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU) characteristics known as possible prognostic markers, and which sociodemographic and psychologic factors associated with VLU are associated with complete healing at 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ambulatory or hospitalized patients
- •patients over 50 years old
- •one or more venous leg ulcer, lasting for 1 month or more
- •wound area more than 1 cm2
- •clinical findings consistent with established venous disease (skin hyperpigmentation, varicose veins, lipodermatosclerosis), confirmed by venous Doppler duplex ultrasonography performed during the preceding 6 months
- •absence of significant arterial insufficiency assessed by clinical findings (intermittent claudication or resting pain, necrotic or distal foot wound) and by an ankle brachial index (ABI) ≥0.8
- •ability to give informed consent
- •ability to be followed for 24 weeks
排除标准
- •ongoing systemic diseases known to be associated with pyoderma gangrenosum or necrotizing vasculitis
- •corticosteroid, cytotoxic or immunosuppressant drug use during the preceding 3 months
- •hypertensive leg ulcer
- •foot ulcer
- •ABI < 0.8
结局指标
主要结局
Healing or non-healing of venous leg ulcers at week 24
时间窗: week 24
Healing or non-healing of venous leg ulcers at week 24
次要结局
- affected-leg characteristics(week 24)
- clinical characteristics(week 24)
- psychologic assessments(week 24)
- cognitive assessments(week 24)
- social assessment(week 24)
- venous leg ulcers inclusion characteristics(week 24)
- venous insufficiency treatment(week 24)
- biologic characteristics(week 24)
研究者
研究点 (70)
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