Diabetes Mellitus, Type 1NCT05935839
Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.
A study testing Multispectral optoacoustic tomography, Ankle Brachial Index and Neuropathy Disability Score in people with Diabetes Mellitus, Type 1 and Macroangiopathy, run by University of Erlangen-Nürnberg Medical School.
Trial summary
In this study, blood flow and tissue changes in adult and pediatric patients with diabetes mellitus will be characterized by MSOT and compared with existing methods (ABI testing, neurological testing) (method comparison). The aim is to quantify changes and to possibly allow early detection of concomitant diseases. Read more about this study
- Who is it for?
- Ages 6 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Macroangiopathy
- What is being tested?
- Multispectral optoacoustic tomography, Ankle Brachial Index and Neuropathy Disability Score
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with diabetes mellitus type 1
- Laboratory-confirmed diagnosis of diabetes mellitus type 1
- Age 18-99 years
- Disease duration of at least 5, preferably 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol)
- Written informed consent
- patients with diabetes mellitus type 1
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- Laboratory-confirmed diagnosis of diabetes mellitus type 1
- Age 6-17 years
- Duration of disease at least 5, better 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol)
- Written informed consent
- Healthy subjects
- Age 18-99 years
- Written informed consent
Who cannot join
- Pregnancy
- Nursing mothers
- Unstable patients: Need for continuous cardiopulmonary monitoring (ECG and pulse oximetry).
- Tattoo in the area of the examination
- Subcutaneous fat over 3 cm
- Lack of written consent
- Inability to perform sufficient (brief) physical exertion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Noninvasive Characterization of Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.
In this study, blood flow and tissue changes in adult and pediatric patients with diabetes mellitus will be characterized by MSOT and compared with existing methods (ABI testing, neurological testing) (method comparison). The aim is to quantify changes and to possibly allow early detection of concomitant diseases. This could, similar to peripheral arterial occlusive disease, lead to a new possibility of non-invasive assessment of disease progression in the future.
Read the detailed description
After informing the patients and parents/guardians and checking the inclusion and exclusion criteria, the clinical data of the ill subjects are recorded and the HbA1c is measured in the laboratory as part of the routine recording. The blood collection is part of the routine diagnostics on presentation in the outpatient clinic and is performed separately from the study.
Subsequently, imaging by MSOT is performed in all study participants. This is performed on both sides of the lower leg over the triceps surae muscle. The examination is analogous to sonography over the corresponding skin layers without further invasive procedures. The anatomical region can be localized by means of built-in sonography; subsequently, the corresponding optoacoustic signals can be derived over it. This is followed by measurement of the Arm-Brachial-Index. After a short recovery time, the test persons perform a physical stress on the examined lower leg muscles. After renewed ABI measurement, the imaging examination is repeated using MSOT. Finally, the neurological status is assessed using the Neuropathy Disability Score (NSS).
- Conditions
- Diabetes Mellitus, Type 1, Macroangiopathy
- Being tested
- Multispectral optoacoustic tomography, Ankle Brachial Index, Neuropathy Disability Score
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral optoacoustic tomographyDevice
Molecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress.
Ankle Brachial IndexDiagnostic test
Dual measurement of ABI index before and after physical exercise.
Neuropathy Disability ScoreDiagnostic test
Single measurement of the NSS
| Study group | Role | What they receive |
|---|---|---|
| Adult Patients with diabetes mellitus type 1 | Experimental | * Laboratory-confirmed diagnosis of diabetes mellitus type 1
* Age 18-99 years
* Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol) Receives: Device: Multispectral optoacoustic tomography; Diagnostic Test: Ankle Brachial Index; Diagnostic Test: Neuropathy Disability Score |
| Pediatric Patients with diabetes mellitus type 1 | Experimental | * Laboratory-confirmed diagnosis of diabetes mellitus type 1
* Age 6-17 years
* Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol) Receives: Device: Multispectral optoacoustic tomography; Diagnostic Test: Ankle Brachial Index; Diagnostic Test: Neuropathy Disability Score |
| Healthy volunteers | Experimental | - Age 18-99 years Receives: Device: Multispectral optoacoustic tomography; Diagnostic Test: Ankle Brachial Index; Diagnostic Test: Neuropathy Disability Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of tissue changes in diabetic patients using MSOT.
Comparison of the quantitative percentage of oxygenated/deoxygenated hemoglobin determined by MSOT in adults and children with diabetes mellitus and an adult healthy control group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935839
- Sponsor's protocol ID
- 23-205-B
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Characterization of Tissue Changes in Diabetes in Adults and Children Using Multispectral Optoacoustic Tomography.
- ClinicalTrials.gov ID
- NCT05935839
- Acronym / sponsor ID
- 23-205-B
- Conditions
- Diabetes Mellitus, Type 1, Macroangiopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, blood flow and tissue changes in adult and pediatric patients with diabetes mellitus will be characterized by MSOT and compared with existing methods (ABI testing, neurological testing) (method comparison). The aim is to quantify changes and to possibly allow early detection of concomitant diseases. This could, similar to peripheral arterial occlusive disease, lead to a new possibility of non-invasive assessment of disease progression in the future.
Detailed description
After informing the patients and parents/guardians and checking the inclusion and exclusion criteria, the clinical data of the ill subjects are recorded and the HbA1c is measured in the laboratory as part of the routine recording. The blood collection is part of the routine diagnostics on presentation in the outpatient clinic and is performed separately from the study.
Subsequently, imaging by MSOT is performed in all study participants. This is performed on both sides of the lower leg over the triceps surae muscle. The examination is analogous to sonography over the corresponding skin layers without further invasive procedures. The anatomical region can be localized by means of built-in sonography; subsequently, the corresponding optoacoustic signals can be derived over it. This is followed by measurement of the Arm-Brachial-Index. After a short recovery time, the test persons perform a physical stress on the examined lower leg muscles. After renewed ABI measurement, the imaging examination is repeated using MSOT. Finally, the neurological status is assessed using the Neuropathy Disability Score (NSS).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult Patients with diabetes mellitus type 1 | Experimental | Device: Multispectral optoacoustic tomography, Diagnostic Test: Ankle Brachial Index, Diagnostic Test: Neuropathy Disability Score* Laboratory-confirmed diagnosis of diabetes mellitus type 1 * Age 18-99 years * Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol) |
| Pediatric Patients with diabetes mellitus type 1 | Experimental | Device: Multispectral optoacoustic tomography, Diagnostic Test: Ankle Brachial Index, Diagnostic Test: Neuropathy Disability Score* Laboratory-confirmed diagnosis of diabetes mellitus type 1 * Age 6-17 years * Duration of disease at least 5, preferably 10 years with inadequate medication control (HbA1c value > 8.5 mmol/mol) |
| Healthy volunteers | Experimental | Device: Multispectral optoacoustic tomography, Diagnostic Test: Ankle Brachial Index, Diagnostic Test: Neuropathy Disability Score- Age 18-99 years |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with diabetes mellitus type 1
- patients with diabetes mellitus type 1
- Healthy subjects
Key exclusion criteria (7 listed)
- Pregnancy
- Nursing mothers
- Unstable patients: Need for continuous cardiopulmonary monitoring (ECG and pulse oximetry).
- Tattoo in the area of the examination
- Subcutaneous fat over 3 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral optoacoustic tomographyMolecular Imaging of tissue changes using MSOT in macroangiopathy in diabetes. Dual imaging before and after physical stress. | Device | Adult Patients with diabetes mellitus type 1, Healthy volunteers, Pediatric Patients with diabetes mellitus type 1 |
| Ankle Brachial IndexDual measurement of ABI index before and after physical exercise. | Diagnostic test | Adult Patients with diabetes mellitus type 1, Healthy volunteers, Pediatric Patients with diabetes mellitus type 1 |
| Neuropathy Disability ScoreSingle measurement of the NSS | Diagnostic test | Adult Patients with diabetes mellitus type 1, Healthy volunteers, Pediatric Patients with diabetes mellitus type 1 |
Primary outcome
Visualization of tissue changes in diabetic patients using MSOT.
Time frame: 12 months
Comparison of the quantitative percentage of oxygenated/deoxygenated hemoglobin determined by MSOT in adults and children with diabetes mellitus and an adult healthy control group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Multispectral optoacoustic tomography, Ankle Brachial Index and Neuropathy Disability Score in people with Diabetes Mellitus, Type 1 and Macroangiopathy, run by University of Erlangen-Nürnberg Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferdinand Knieling, PD Dr. med. (+49 9131 85 41337, ferdinand.knieling@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of tissue changes in diabetic patients using MSOT. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023; AzTrials last refreshed its copy on 31 Oct 2026.