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临床试验/NCT01614379
NCT01614379撤回不适用

Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs

Aarhus University Hospital2 个研究点 分布在 1 个国家开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2

研究概览

简要总结

Diabetic foot ulcers often progresses after many years of diabetes where the patients system is so damaged that normal heeling of ulcers cannot happen. The physician at the clinic examines the foot, measuring its circulation and sensitivity. The measures are the blood pressure in comparison between foot and upper arm and oxygen level in the foot. The measurements have a direct connection to the blood circulation, but it doesn't visualize the blood circulation.

Development of MR methods without the use of contrast agents have become so good that images of the blood veins can be used in treatment. This means that the MR images provide important information about the patient vessel wall stiffness and blood circulation without the use of the damaging substances. Hence the physician can perform the MR examination and in comparison with the test performed at the clinic he can make an improved and without risk diagnose. Using MR at a lot earlier stage in the treatment is expected to reduce the number of amputations. This is not only an economic advantage, but also an improvement of the patient quality of life.

The objective of the study is to investigate type 1 diabetics oxygen level, vessel wall stiffness, blood circulation, tissue contribution and blood pressure in the foot with the use of conventional measurements in their treatment and with the added use of MR methods.

This will provide the physician with valuable information of the patient illness and is expected to play an important role in the prevention of diabetic foot ulcers. We expect that MR research leads to a much improved prevention and treatment of aggressive and destructive diabetic foot ulcers. This will increase the general quality of life and reduce the large number of amputations performed every year.

详细描述

NON-ENHANCED MAGNETIC RESONANCE ANGIOGRAPHY OF DIABETIC ISCHEMIC LOWER LIMBS

BACKGROUND

Diabetic foot ulcers often progresses after many years of diabetes where the patients system is so damaged that normal heeling of ulcers cannot happen. The patient seeks a doctor and he sends the patient to the ulcer clinic or an ulcer specialist. The physician at the clinic examines the foot, measuring its circulation and sensitivity. The measures are the blood pressure in comparison between foot and upper arm and oxygen level in the foot. The measurements have a direct connection to the blood circulation, but it doesn't visualize the blood circulation.

Visualization of the circulation is often achieved with medical imaging methods such as x-ray and MR. The problem with the current use of these methods is the added use of contrast agent. This is especially a problem with the diabetics who have reduced kidney function, where to this method is poisonous to the kidneys. That is why the methods often are only used right before a scheduled amputation, so the surgeon can plan the amputation.

Development of MR methods without the use of contrast agents have become so good that images of the blood veins can be used in treatment. This means that the MR images provide important information about the patient vessel wall stiffness and blood circulation without the use of the damaging substances. Hence the physician can perform the MR examination and in comparison with the test performed at the clinic he can make an improved and without risk diagnose. Using MR at a lot earlier stage in the treatment is expected to reduce the number of amputations. This is not only an economic advantage, but also an improvement of the patient quality of life.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • 未提供

排除标准

  • If subject does not apply to the MR safety rules.
  • Less then 18 years old.
  • Has a planed amputation of a lower extremity as part of treatment.
  • Diabetic foot ulcer with a Wagner score of 3-
  • Internal insulin pump.

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Vaeggemose

Research Assistant

Aarhus University Hospital

研究点 (2)

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