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Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Michael Vaeggemose, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01614379
First received: June 5, 2012
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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
Diabetes Mellitus, Type 1
Ischemia
Foot Ulcer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Biospecimen Retention:   Samples Without DNA

Blood sample less then 250ml to determine Hba1c (blood glucose level).


Enrollment: 0
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)
Groups/Cohorts
Healthy control subject
10 healthy control subjects for statistical comparison
Type 1 diabetic patient
40 type 1 diabetic patients with diabetic foot ulcers.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614379

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

No publications provided

Responsible Party: Michael Vaeggemose, Research Assistant, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01614379     History of Changes
Other Study ID Numbers: 2012-33818
Study First Received: June 5, 2012
Last Updated: April 11, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on November 20, 2014