Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs
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.
Diabetes Mellitus, Type 1
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs|
Blood sample less then 250ml to determine Hba1c (blood glucose level).
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Healthy control subject
10 healthy control subjects for statistical comparison
Type 1 diabetic patient
40 type 1 diabetic patients with diabetic foot ulcers.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01614379
|Department of Endocrinology|
|Aarhus, Denmark, 8000|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Michael Vaeggemose, MSc||Department of Endocrinology and Internal Medicine, Aarhus University Hospital|