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临床试验/NCT06834555
NCT06834555尚未招募不适用

Can Mobile Phone Thermal Imaging Provide an Ambulatory Assessment of Incompetent Perforator Veins?

Guangdong Second Provincial General Hospital0 个研究点目标入组 100 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
sensitivity and specificity of smartphone thermal imaging in diagnosing and locating the insufficient perforated vein in CVD patients

研究概览

简要总结

Chronic venous disease is a common disease of the lower limbs. Severe CVD can lead to lower limb swelling, pigmentation, and repeated skin ulceration, which seriously affects patients' quality of life. About 10.5% to 92.7% of CVD patients with recurrent varicose veins had insufficient perforating veins. Treatment of these IPVs can promote venous ulcer healing and reduce the recurrence rate of venous ulcers. Accurate assessment and positioning of insufficient perforating veins in the lower leg is a key step in developing a personalized treatment strategy. At present, Color Doppler ultrasonography performed in the upright position in combination with the Valsalva maneuver or local pressure of the limb is regarded as the "gold standard" for the diagnosis of perforating veins insufficiency. However, in China, a large number of perforating veins insufficiency are diagnosed by venography. Because the majority of Chinese vascular surgeons are not versatile in vascular ultrasound examination and venous ultrasound protocols vary from institution to institution. A non-functioning valve in an insufficient perforated vein allows blood to flow retrograde from a deep vein to a superficial vein. Some researchers have shown that the venous blood temperature of deep veins is higher than that of superficial veins. Thus, the retrograde flow of "warm blood" from the deep vein to the superficial vein increases the skin temperature located on the insufficient perforated vein. This study tested the feasibility of a smartphone and its compatible portable thermal imaging device as a tool for assessing insufficient perforated vein. The objective is to study the sensitivity and specificity of smartphone thermal imaging in diagnosing and locating the insufficient perforated vein in CVD patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • A diagnosis of CVD by vascular surgeon, classified C0 to C6 according to CEAP (Clinical-Etiology - Anatomy - Pathophysiology) No history of lower extremity surgery The body mass index (BMI) is 18 to 35 kg/m2

排除标准

  • deep vein thrombosis heart disease peripheral artery disease chronic liver disease chronic kidney disease pregnancy severe obesity (BMI ≥35 kg/m2)

结局指标

主要结局

sensitivity and specificity of smartphone thermal imaging in diagnosing and locating the insufficient perforated vein in CVD patients

时间窗: 10 months

次要结局

未报告次要终点

研究者

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

Hao Liu

Attending Doctor

Guangdong Second Provincial General Hospital

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