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临床试验/NCT07334028
NCT07334028招募中不适用

Observational Study to Ascertain the Optimum Time to Observe the Infra-red Image of Varicose Veins in the Lower Limb When Standing From a Supine Position.

The Whiteley Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月26日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Time of optimal Infrared imaging of leg varicose veins after standing from lying

研究概览

简要总结

The goal of this observational study is to identify the optimal time of Infrared imaging of varicose veins when patients move from a lying to a standing position.

The primary purpose is to enable us to improve our imaging of varicose veins in patients presenting with primary or recurrent leg varicose veins.

The main questions it aims to answer are:

Outcome measure 1- How long after standing up from lying supine do leg varicose veins show up best on infrared imaging? Outcome measure 2 - Is there any difference in this timing between varicose veins arising from different sources in the leg?

Patients will be asked to stand, and sequential infrared images will be taken every 5 seconds for 3 minutes.

详细描述

Patients who are having a Duplex ultrasound of their lower-limb veins for the assessment of varicose veins (primary or recurrent) and who have consented to participation in the study will be taken from the scanning room to the research room (within 20 meters).

The patient will be asked for their height and weight to enable BMI to be calculated. The patient will then lie down horizontally for 5 minutes on a bed in the research room. At the end of the 5 minutes, an IR image will be taken of the participant's lower limbs to ensure clearance of varicose veins.

The patient will then be asked to stand in front of an IR camera on a mat with marked positions for their feet on the floor in a position ensuring maximum surface area coverage of lower-limb varicose veins by the camera. The patient will stand still for a period of 3 minutes whilst the IR camera (HIKMICRO M10) takes a series of JPEG photos every 5 seconds. The position of the camera will be adjusted so that the top of the image is at the level of the hip, and the bottom of the image at the sole of the foot. Hence, the image size will be maximised to include the whole leg.

The first image will be taken immediately the patient stands and is in position, minimising any lag and aiming to be within 5 seconds of starting to move from the supine position. After 3 minutes, the patient will be able to sit down and then return to the consultation room.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients undergoing venous duplex ultrasound scan for suspected varicose veins (primary or recurrent).
  • Able to stand still for 5 minutes.
  • Able to get on to and off of the surgical couch unaided.
  • Patient giving consent.

排除标准

  • Refusing consent.
  • Unable to get on a couch or stand unaided.
  • Unable to stand still for 5 minutes.

结局指标

主要结局

Time of optimal Infrared imaging of leg varicose veins after standing from lying

时间窗: The whole process for the patient will be a maximum of 20 minutes. The analysis of all of the images will be completed within 1 month of the end of the data collection.

Sequential infrared images will show us at what time point the optimal infrared images have been obtained.

次要结局

  • Variation of optimal infrared image timing due to the source of venous reflux(The patient data collection will be within 20 minutes, and the analysis within 1 month.)

研究者

发起方
The Whiteley Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Whiteley

Consultant Venous Surgeon

The Whiteley Clinic

研究点 (1)

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