Does Use of a Wound After-care Summary for Patients With a History of Venous Ulcers Lower Recurrence Rate?
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Ulcer-free survival period
研究概览
简要总结
The purpose of this study is to determine whether individualized wound prevention instructions will lengthen the ulcer-free period in veterans with recently healed venous ulcers.
详细描述
Venous ulcer disease is the most common form of lower extremity ulcer, and treatment requires months to years of costly intervention. Preventing venous ulcers from recurring is ideal, however, healing time is variable, possibly due to inadequate patient/clinician communication and surveillance. An aftercare summary is a detailed set of self-care instructions designed to help patients understand and influence preventative factors under their control. They have successfully been used in patients with cardiac disease and are currently being tested to help prevent diabetic foot ulcers. We propose the use of an aftercare summary to help prevent ulcer recurrence in veterans with recently healed venous ulcers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Confirmed venous ulcer (ICD-9: 454.0, 454.2, 459.11, 459.13, 459.31, 459.33);
- •Documented healing of all lower extremity ulcers;
- •Ankle-brachial index (ABI) > 0.8 to rule out arterial insufficiency
排除标准
- •Unwilling or unable to sign informed consent;
- •No plans to seek care at VA Puget Sound within 6 months;
- •Limbs with ulcers or threatened viability
结局指标
主要结局
Ulcer-free survival period
时间窗: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm)
次要结局
- Adherence with self-management goals(Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.)
- Change in quality of life(Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.)
- Change in satisfaction with care(Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.)