Molecular and Genetic Analysis of Disturbed Wound Healing in Barbadians With Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 入组人数
- 605
- 试验地点
- 1
- 主要终点
- Genetic Phenotyping (Haptoglobin and TRAPS)
研究概览
简要总结
This observational study aims to identify risk factors and molecular mechanisms of impaired wound healing, to guide better foot care in the diabetic population.
详细描述
Diabetes is linked with vascular complications of the eye, kidney and foot. Barbadians suffer from an unusually high prevalence of diabetic foot complications, which can cause difficult-to-heal foot ulcers and even lead to amputations of the toes or feet.Studies from the CDRC have indicated alarmingly high rates of amputation and mortality due to diabetic foot in Barbados. The goal of this study is to improve early detection of persons at risk of the vascular complications of diabetes through non-invasive scanning and genetic susceptibility tests.
The general hypothesis to be tested in this study is that persons with diabetes (PWD) and non-healing foot ulcers are more likely to have a disturbed mechanism for wound-healing than PWD without this particular complication. If the hypothesis is proven correct, this will empower patients and physicians with the diagnostic tests to make early interventions towards avoiding the complications of diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of diabetes
- •Barbadian national
- •self reported ethnicity of Black/African descent
- •clear knowledge of ulcer history
排除标准
- •no clinical diagnosis of diabetes
- •non-national of Barbados
- •self reported ethnicity not Black/African Descent
- •unclear knowledge of ulcer history
结局指标
主要结局
Genetic Phenotyping (Haptoglobin and TRAPS)
时间窗: 18 months
次要结局
- Reactive Hyperemia Index and Augmentation Index(18 months)
- Depression(18 months)
- Quality of Life(18 months)