Non-enhanced Magnetic Resonance Angiography of Diabetic Ischemic Lower Limbs

NCT01614379 | Withdrawn DMC

• 1 other identifier: 2012-33818
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 1; Ischemia; Foot Ulcer

Study Arms (2)

Healthy control subject

10 healthy control subjects for statistical comparison

Type 1 diabetic patient

40 type 1 diabetic patients with diabetic foot ulcers.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (2)

Department of Endocrinology

Aarhus, Denmark, 8000, Denmark

Location

MR Centre

Aarhus, Denmark, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Ischemia; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Michael Vaeggemose, MSc

  Department of Endocrinology and Internal Medicine, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 7, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

DK (2)