Microangiopathy IN Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Peak perfusion in response to local thermal hyperemia
研究概览
简要总结
This clinical trial aims to evaluate the use of a contactless and non-invasive technique to measure the properties of the skin's microcirculation and its regulatory functions in both healthy individuals and patients with microvascular disease associated with type 1 diabetes. It is hoped that the study results will lead to the development of a useful method for detecting diabetic complications at an early stage, thereby enabling treatment and preventive measures before the onset of severe microangiopathy.
详细描述
This study will employ investigational devices to evaluate microvascular function and correlate it to degree of microangiopathy in persons with diabetes type 1 and healthy controls.
The investigational device, TCI P4, is a novel, contactless, non-invasive, non-CE marked, class IIa Spatial Frequency Domain Imaging (SFDI) system. The device utilizes an LED light projector to cast patterned, multi-wavelength light onto the skin while multiple cameras capture narrow-band reflections. This method yields two-dimensional data on skin structure and molecular composition (including hemoglobin, oxygen, and water). Established comparators such as laser speckle contrast imaging (LSCI) and the EPOS system are employed to benchmark device performance and validate measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetes mellitus type
- •Cohort specific inclusion criteria apply, please review 'groups' section.
排除标准
- •Patients unable to understand patient information due to cognitive impairment.
- •Patients unable to understand patient information due to language barriers.
- •Ongoing acute infection disease or inflammatory condition.
- •Pregnant or breast-feeding women.
- •Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices.
结局指标
主要结局
Peak perfusion in response to local thermal hyperemia
时间窗: Investigation will take within 1 day from enrollment.
As measured with investigational devices TCI P4, Pericam LSCI and EPOS devices.
次要结局
- Perfusion heterogeneity in sole of feet(Investigation will take place within 1 day from enrollment.)
研究者
Sara Tehrani
Principal investigator, Medical doctor, Specialist in internal medicine
Karolinska Institutet