Clinical Implications of Genetic Variations of Venous Stasis Ulceration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 377
- 试验地点
- 2
- 主要终点
- Ulcer healing
研究概览
简要总结
Currently, there is no standard approach for the treatment of patients with venous stasis ulcers, and no means of accounting for the genetic factors that may contribute to a patient's response to different therapeutic interventions. In order to determine whether, or to what extent, genetic profiling of venous stasis ulcers can stratify patients according to their potential for disease progression or healing, and guide preventive strategies and levels of therapeutic interventions, the study will involve retrospective genetic profiling of patients with a healed or persistent venous stasis ulcer as a means of determining the efficacy of current therapies, and to establish a future prospective evaluation of treatment algorithms based on genetic phenotype and variation. Results obtained from the 2 aforementioned groups of participants will be compared with those of a control group of participants who have no history of venous ulcer nor peripheral vascular disease.
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详细描述
A blood specimen will be drawn, medical and medication history taken, and wound/s will be assessed and followed for 2 years in regard to the enrollees w/active venous ulcer/s or healed venous ulcer/s.
A venous duplex ultrasound of right and left lower extremities will be done at no cost, a blood specimen will be drawn, and medical and medication history will be taken in regard to control group enrollees.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •>/=18y.o.
- •active venous ulcer (CEAP 6)
- •healed venous ulcer (CEAP 5)
排除标准
- •<18 y.o.
- •inability to comply w/compression therapy
- •Inability to maintain f/u schedule
- •ABI (ankle-brachial index) < 0.5 if pedal pulses are not palpable
- •Inability to ambulate w/active ulcer (N/A for Group 2)
- •Diabetic w/ABI <0.5
- •Severe premorbid systemic disease such as pulmonary failure, heart failure, renal failure, or hepatic failure w/a life expectancy of <1 year
- •Chronic steroid therapy Group 3-Controls
- •Inclusion Criteria:
- •>/= 50y.o.
- •no reported clinical symptoms of venous disease
- •(CEAP 0 or 1)
- •Exclusion Criteria:
- •ABI (ankle-brachial index) < 0.5 if pedal pulses are not palpable
- •Diabetic w/ABI < 0.5
- •Severe premorbid systemic disease such as pulmonary failure, heart failure, renal failure, or hepatic failure w/a life expectancy of <1 year
- •Chronic steroid therapy
结局指标
主要结局
Ulcer healing
时间窗: Assessment made when batch of samples (360) obtained
Time to ulcer healing
Ulcer recurrence
时间窗: Assessment made when batch of samples (360) obtained
Presence of ulcer recurrence
次要结局
- Analysis of genetic variation in concert with ulcer healing, time to healing and recurrence(Assessment made when batch of samples (360) obtained)
研究者
Rabih A. Chaer
MD
University of Pittsburgh