The Diabetic Foot: Relevance of Vascular Progenitor Cells as a Prognostic Marker of Cardiovascular Mortality, Restenosis, and Atherosclerotic Disease Progression in Treated Limb.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- post revascularization cardiovascualr mortality
研究概览
简要总结
Type of Study: Pilot Study monocenter Study Duration: 18 months Subject Participation Duration: The patients are enrolled for the time of the blood withdrawl.
Follow up visit will be after 12 months from the enrollement.
Objectives:
The project will have two major objectives:
A)To validate the prognostic value of vascular progenitor cells, identified by flow cytometric analysis of antigenic phenotype, in a cohort of 109 patients with type-2 diabetes complicated by ischemic foot ulcers. Events are: cardiovascular mortality, major amputation, post-angioplasty restenosis , and development of new atherosclerotic plaques in treated limb B)To determine the mechanisms responsible for vascular progenitor cell dysfunction in the perspective of new therapies for the cure of the diabetic foot.
详细描述
This collaborative project aims to produce significant outputs for the identification of patients requiring intensification of therapy. Furthermore, the project will fill the gap in current knowledge on the post-genomic alterations that render diabetic vascular progenitor cells dysfunctional. In perspective, this might help us to design new therapies for the cure of the diabetic foot, including but not limited to stem cell therapy.
Primary Objectives:
To validate the prognostic value of vascular progenitor cells, identified by flow cytometric analysis of antigenic phenotype, in a cohort of 109 patients with type-2 diabetes complicated by ischemic foot ulcers.
Events are:
Cardiovascular mortality Major amputation Post-angioplasty restenosis Development of new atherosclerotic plaques in treated limb (follow up: 12 months).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Adult diabetic patients type 1 or 2
- •Chronic critical ischemia as defined by TASC 2007 criteria (pain at rest, and/or ulcer or gangrene due to artheropaty: transcutaneous oximetry < 30 mmHg or pressure on the ankle < 70 mmHg)
排除标准
- •Cancer with adverse prognosis in months, or chemotherapic treatment
- •Ongoing or planned pregnancy
- •Lack of consent to participate to the study
结局指标
主要结局
post revascularization cardiovascualr mortality
时间窗: 18 months
次要结局
- post revascularization amputation(18 months)