Infrared Thermal Imaging in Evaluating the Percutaneous Transluminal Angioplasty for Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine the validity and reliability of IRTI in assessing foot blood perfusion and surgical success rate after PTA treatment.
研究概览
简要总结
Determination of IRTI (infrared thermal imaging) can be used to evaluate PAD patients with critical limb ischemia with different degrees of lesion.
IRTI can be used to evaluate the foot blood perfusion after percutaneous transluminal angioplasty (PTA) treatment and determine the success rate of surgery.
IRTI can be used as an effective follow-up tool for patients after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Rutherford grade 3, 4, 5, or
- •Patients with indications for lower extremity arterial PTA: severe intermittent claudication, rest pain, ulceration or gangrene.
- •Patients who required PTA of only one limb (left versus right).
排除标准
- •Patients with body temperature above 37 ° C.
- •Patients with indications for open surgery.
- •Patients requiring major amputation (above the ankle).
- •Patients with acute occlusive or embolic limb ischemia.
- •Patients with deep venous thrombosis of the lower extremity.
结局指标
主要结局
To determine the validity and reliability of IRTI in assessing foot blood perfusion and surgical success rate after PTA treatment.
时间窗: up to 15 months
The different levels of pseudocodes (white, red, pink, yellow, green, blue, and black) represent the corresponding IRTI, corresponding to the color bar from low to high temperature. We will measure the average temperature of the dorsum and sole of the foot before and after PTA treatment in the operated and non-operated limbs. Ankle-brachial index (ABI) of the operated and non-operated limbs before and after PTA treatment will also be measured. We will analyze the agreement between ABI and foot temperature in the operated and non-operated limbs, as well as the agreement between the change in ABI and foot temperature.
次要结局
未报告次要终点
研究者
Fangge Deng
: Principal Investigator
The First Affiliated Hospital of Guangzhou Medical University