Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Barefoot plantar pressure
研究概览
简要总结
Diabetes is a chronic disease with increasing prevalence worldwide with a high burden to individuals and the society and it is expected to be the 7th leading cause of death in 2030. Diabetes related complications manifest in many body parts, often in the foot, due to reduced blood flow and nerve damage, increasing the risk of ulcers and amputation. High plantar pressures during walking contribute to the development of foot ulcers and foot ulcer recurrence. Emerging studies also point skin temperature as another predictor of foot ulceration. However, the number of studies including prediction models of plantar pressure and skin temperature are scarce, especially in patients with confirmed diagnosis of diabetic foot and a history of foot ulcer. Factors like mobility, hardness of plantar soft tissue, foot deformities and other diabetes related characteristics have been related to plantar pressure measurements but not to foot skin temperature measurements, and the relation between skin temperature and plantar pressure has not been much explored in the literature. The role of these variables in the development of foot ulceration needs further attention, especially in patients with history of foot ulcers has they are at the highest risk to develop a foot ulcer.
Therefore, the goal of this research is to determine which variables can be used to predict plantar pressure and skin temperature and which factors are associated with the development of foot ulcers in patients with established diagnosis of diabetic foot. The associations between skin temperature and plantar pressure will also be addressed.
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
- 是
入选标准
- •Adults (over 18 years)
- •Diagnosed as diabetic foot patient
- •Able to walk 10 meters without assistance
排除标准
- •Non-cooperating patients
- •Patients with major amputations
- •Patients with a draining ulcer and/or infection
- •Patients with cognitive impairments
结局指标
主要结局
Barefoot plantar pressure
时间窗: At study entry
Barefoot plantar pressure will be assessed using a pressure platform.
Percentage of patients developing a foot ulcer
时间窗: One year after enrollment
The occurrence of foot ulceration will be assessed during a period of 1 year.
Skin temperature
时间窗: At study entry
After an acclimation period of 10 minutes, skin temperature of the sole and dorsum of the foot will be assessed with a thermographic camera. Thermograms will be captured before, immediately after and five minutes after a two-minute cold stress test using an aluminium plaque.
次要结局
- Hallux active extension range of movement(At study entry)
- Soft tissue hardness(At study entry)
- Ankle mobility(At study entry)
- In-shoe plantar pressure(At study entry)
- Time to ulceration(At study entry)
研究者
Adérito Seixas
PhD Student
Universidade do Porto
