Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01614379 |
| Other study ID # |
2012-33818 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
June 5, 2012 |
| Last updated |
April 11, 2013 |
| Start date |
June 2012 |
| Est. completion date |
June 2013 |
Study information
| Verified date |
April 2013 |
| Source |
Aarhus University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics |
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
The use of MR technique will furthermore provide the physician with the possibility to
create a 3D model of the foot, with segmentation of the different types of tissue in the
foot. This makes a single MR scan provide the physician with important information of the
physiology (how the foot works), the placement of the ulcer, shape, depth and tissue
contribution.
INVESTIGATOR, SPONSOR AND TRAIL SETTING
Michael Vaeggemose is the investigator and will perform the conventional test at the
Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Nørreborgade
44, 8000 Aarhus, Denmark. Furthermore Michael will perform the MR scans at the MR Centre,
Aarhus University Hospital, Skejby, 8200 Aarhus N, Denmark.
The blood test which is included in the project will be performed by a laboratory technician
at the Department of Endocrinology and Internal Medicine. The test is used to determine
blood glucose (the sugar level of the blood) and will be destroyed after the examination.
There will not be established a biological bank in this project.
Physician Niels Ejskjaer from the Department of Endocrinology and Internal Medicine is
attached to project as responsible physician. Niels Ejskjaer will furthermore work as
supervisor of the investigator and is the sponsor of this research project.
OBJECTIVE
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.
METHODS
The study is an investigation of MR methods in the treatment of diabetic foot ulcers. The
trial consists of 5 physiological examinations and a blood test. To make sure that all the
test subjects (diabetics and healthy controls) receive the same treatment is the test
performed by the same investigator, with an exception of the blood test which will be
performed by the laboratory technician. The 4 test are known to the diabetic patients from
earlier clinical trials performed in relation to the treatment of their ulcers, alas they
will have to be performed again. Due to logistics the participants can experience more than
one day of trail, since the MR clinical and the Department of Endocrinology and Internal
Medicine is not placed in the same part of town.
The blood test is used to determine the subjects' blood glucose (the level of sugar in the
blood) and will after use be destroyed. Blood glucose level gives a well-defined measure of
diabetes. Therefore it is an important measure in the comparison between the conventional
test and the MR imaging. Do the blood glucose levels correlate with the findings of the 5
tests then the results of the statistics are plausible and significant results are accepted.
Tree of the test are made in regard to the pulse in the foot. The pulse is measured several
places by placing the finger on one of the blood veins in the foot and then count the number
of pulse ripples each minute. This is a very simple measurement but effective in estimating
the condition of the circulation in the foot. The trails include a more advanced method to
measure the pulse at the ankle, middle foot and in the toes compared with the pressure in
the arm give an indication of reduced circulation in the specific areas. The measurements
are performed with ultrasound and pressure sensitive sensors placed on the pulsating veins.
The fourth examination measures the oxygen level in the foot. Diabetics with foot ulcers
often have reduced oxygen level in the feet, which makes the heeling slow and troublesome.
This makes the oxygen levels an important measure which is measured in a device connected to
the patient with electrodes. The first 4 measurements are all conventional measurements used
and performed in the clinic doing the normal treatment of their ulcers.
The MR measurement is used to determine the anatomy and function of the foot. De different
scan sequences makes it possible to visualize blood vessels, tissue contribution, oxygen
levels and through data processing vessel wall stiffness. Several of the scan sequences are
recorded in synchrony with the heart rhythm. The rhythm is recorded wireless with and ECG
device after placing of 3 electrodes. The scan time can vary, due to the subjects different
heart rates in practice this means that the MR scans takes from 30 min to 60 min.
STATISTICAL CONSIDERATIONS
Sensitivity and specificity of the MR methods will be evaluated I relationship to the
conventional applied methods (pulse and oxygen level measurements) which will be performed
at the Department of Endocrinology and Internal Medicine. From a McNemar's test with a
significant level of 5% a power calculation were performed giving a needed sample size of 40
type-1 diabetic patients and 10 healthy control subjects. To perform the statistical
calculations assumptions of the sensitivity and specificity have been made. Due to the
assumptions a pilot study will be performed with 5 diabetic patients showing if the MR
method produces enough signal to make the need examination.
VOLUNTEERS
The trails consist of 10 healthy (don't use prescribed medicine) and 40 type-1 diabetic foot
ulcer patients. Subjects from both groups are at least 18years old and have received oral
and written information regarding the project and afterward given informed consent of
participation in the project. Furthermore a requirement of the diabetic foot ulcers is that
the ulcer must have a reduced oxygen level.
Subjects will be excluded if they have metal in the body or are scheduled to have an
amputation as part of their treatment.
SIDE EFFECTS, RISK AND DISADVANTAGES
Oxygen level and pulse examinations meet the requirements of patient safety and are used in
a large number of examinations. There are no known risks in the used methods but should
there be an unpleasantness or problems from regarding the participation the patient must
contact the investigator at once.
MR scans is also not connected to any known risks and the patients ears will be protected
with soundproofing earplugs or headphones to avoid the discomfort in relation to the high
sound the scanner makes during the scans. The patient will be placed outside the scanner,
with the feet sticking into the scanner, removing the risk of making the patient feel
claustrophobic.
The blood test can be connected to slight discomfort and a small risk of developing
accumulation of blood and infection at the needle injection site. If any sign of infection
(rash, heating, tenderness, swelling) the subject must seek the investigator or the
emergency room. Det combined blood loss in connection to the blood test will not exceed
250ml, which is a lot less than a blood donation includes.
The blood test is analysed and destroyed after. A biobank will not be established in this
project.
ECONOMIC CONDITIONS
Expenses in connection to the project are covered by the involved departments. The
researchers have no economic conflict of interest in the project. Transport expenses in
connection to oral information and examination is refunded in regard to the guidelines used
at the departments. In regard to national guidelines the subjects will be paid compensation
for their partition in the project.
PUBLICATION OF RESULTS
The results will be published in a recognized international paper regardless of the results
are positive, negative or if the method is not good enough to determine a statistical
significant difference.
Do the subjects wish information about the project results they can inform the investigator
and he will send the information to the interested subjects.
NATIONAL ETHICAL COMMITTEE REVIEW
The project is reported and approved by the Danish Data Protection Agency (nr.
2007-58-0010), Danish National Committee on Health Research Ethics (nr. 2012-33818) and the
department legislations.
VOLUNTEER RECRUITMENT
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. If a patient agree to participate he/she will
receive information of the project and information of participation in research projects
(Forsøgspersonernes rettigheder i et sundhedsvidenskabeligt forskningsprojekt) written by
the Danish National Committee on Health Research Ethics.
Latest a week after receiving the information investigator Michael Vaeggemose will contact
the subject and ask if he/she still wishes to participate and would like to hear more about
the aspects of the project. Furthermore the patient will be invited to a personal
conversation with the possibility to have a trusted friend in the room that can help the
patient in the choice of participating in the project. 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. The conversations (diabetic and control) will be held undisturbed in one
of the department rooms. At the conversations it will be stretched that participating is
volunteer and as a volunteer you can chose to stop you participation at any point in the
project, without it having any effect on their following treatment. During the conversation
the patient is given the written consent document which must be signed before the trails can
begin. The patient has a week to evaluate the project from this point and will then receive
a call from the investigator regarding the final decision of participating in the project.
