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临床试验/NCT03254095
NCT03254095已完成不适用

Thermal and Biomechanical Characterization of Diabetic Foot Patients, Predictors of Skin Temperature, Barefoot Plantar Pressure and Ulceration.

Universidade do Porto0 个研究点目标入组 54 人开始时间: 2016年9月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adérito Seixas

PhD Student

Universidade do Porto

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