Image Features of LSCI and Thermography for Determining the Risk Factor (0,1,2 and 3) of Developing Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Perfusion units at various regions of interest using LSCI
研究概览
简要总结
Diabetic foot ulcers are one of the complications of diabetes mellitus. These wounds are often the result of diabetes-related neuropathy and/or an ischemic foot. Even with great care, recurrent ulcers are common. To mediate the damage and societal costs that come with DF there is a need for applications to detect ulcers before they come apparent. Two of these promising techniques are Laser Speckle Contrast imaging and thermography. This study is part of 4 specific clinical studies and is aimed at determining Laser Speckle Contrast imaging and thermography features, the provocations that are needed to optimize imaging and the correlation between these features and the IWGDF risk stratification category system for the diabetic foot.
详细描述
Diabetic foot ulcers are one of the complications of diabetes mellitus. These wounds are often the result of diabetes-related neuropathy and/or an ischemic foot. Diabetic feet (DF) are ideally treated by a multidisciplinary wound care team. Patients at high risk and especially patients that suffer from DF before will have to be checked regularly for new wounds.
Even with great care, recurrent ulcers are common. To mediate the damage and societal costs that come with DF there is a need for applications to detect ulcers before they come apparent. To improve care, an application to predict the healing status is desired.
To this purpose, a set of four (4) specific clinical studies has been conceived to tackle the overall challenging objectives to characterise the risk of ulcers in different patients and through different measurement conditions, including conditions of how a tele-home care service can be deployed. This is clinical study A.
This study investigates two techniques:
Laser speckle contrast imaging (LSCI) is a promising non-invasive technique to assess microcirculation. LSCI, exploits the random speckle pattern that is generated when tissue is illuminated by laser light and changes when blood cells move in the sampled tissue.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The sample will include all the people who sign the informed consent.
- •Patients above
- •Patients diagnosed with Diabetic feet.
- •Patients with Risk Level 0, 1, 2 and 3 according to the International Working Group on the Diabetic Foot - IWGDF).
排除标准
- •People who do not give their consent to participate in the study.
- •Patients with active wounds on one or both feet.
结局指标
主要结局
Perfusion units at various regions of interest using LSCI
时间窗: During one outpatient visit (30 minutes)
Maps of perfusion units will be gathered for different risk groups. The perfusion units will be used to create risk features together with thermography .
Temperature at various regions of interest using thermography
时间窗: During one outpatient visit (30 minutes)
Maps of perfusion units will be gathered for different risk groups. The Temperature will be used to create risk features together with perfusion units from LSCI .
Correlation of the above features with the chance of developing ulcers (Risk 0, Risk 1, Risk 2 and Risk 3).
时间窗: Year 4
A first attempt will be made to find a correlation between perfusion and temperature and how these differ depending on the risk factor.
The effect of provocations performed prior to measuring with LSCI
时间窗: During one outpatient visit (30 minutes)
For both LSCI and thermography the circulation in the leg will be provoked using the leg raise maneuver or a pressure cuff. The effect on both measurements with and without these provocations will be evaluated.
The effect of provocations performed prior to measuring with thermography
时间窗: During one outpatient visit (30 minutes)
For both LSCI and thermography the circulation in the leg will be provoked using the leg raise maneuver or a pressure cuff. The effect on both measurements with and without these provocations will be evaluated.
次要结局
- Gathering data for AI (artificial intelligence) risk factor analysis in MYFOOT study(Year 4)
- Assessing the practical needs for transferring measurements to a different environment (e.g., home) by interviewing the clinicians involved in the consortium.(Year 3)
研究者
KilianKappert
Principal Investigator
Ziekenhuisgroep Twente