Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01614379
Recruitment Status : Withdrawn
First Posted : June 7, 2012
Last Update Posted : April 12, 2013
Information provided by (Responsible Party):
Michael Vaeggemose, Aarhus University Hospital

Brief Summary:

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.

Condition or disease
Diabetes Mellitus, Type 1 Ischemia Foot Ulcer

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs
Study Start Date : June 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Healthy control subject
10 healthy control subjects for statistical comparison
Type 1 diabetic patient
40 type 1 diabetic patients with diabetic foot ulcers.

Biospecimen Retention:   Samples Without DNA
Blood sample less then 250ml to determine Hba1c (blood glucose level).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Diabetic subjects with foot ulcers will be asked of interest to participate in the study, when visiting the clinic in connection to their regular treatment at the clinic. Staff physician Niels Ejskjaer is treating a large part of the patients and will after their visit at the clinic ask the patients of participation, with stretch on that it's voluntary and it has not effect of their regular treatment.

The healthy control subjects will be recruited from posters calling for participants to contact the investigator on phone or mail. The posters will have information about the project but information on the phone and invitation to a personal conversation with a trusted friend will be offered, as it is to the diabetic patients.


Inclusion Criteria (diabetic group):

  • Type 1 diabetic patient with ischemia in the lower extremities determined from conventional clinical measurements (palpable foot pressure, ankle-brachial index, transcutaneous oxygen level, toe pressure).
  • Diabetic foot ulcer with a Wagner score of 0-2.

Inclusion Criteria (healthy control group):

  • Do not use prescription drugs.
  • BMI is between 20 and 30.

Exclusion Criteria:

  • 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 3-5.
  • Internal insulin pump.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01614379

Department of Endocrinology
Aarhus, Denmark, 8000
MR Centre
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Principal Investigator: Michael Vaeggemose, MSc Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Responsible Party: Michael Vaeggemose, Research Assistant, Aarhus University Hospital Identifier: NCT01614379     History of Changes
Other Study ID Numbers: 2012-33818
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: April 12, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Foot Ulcer
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Autoimmune Diseases
Immune System Diseases