Diabete MellitusNCT07306884
Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy
A study testing Nerve conduction study, Nerve ultrasound and Autonomic assessment in people with Diabete Mellitus and Peripheral (Sensorimotor) Diabetic Polyneuropathy, run by Assiut University at 1 site in Egypt.
Trial summary
Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Mellitus, Peripheral (Sensorimotor) Diabetic Polyneuropathy
- What is being tested?
- Nerve conduction study, Nerve ultrasound and Autonomic assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years with type 1 or type 2 diabetes (with or without diabetic peripheral neuropathy), and age and sex-matched healthy controls
Who cannot join
- Other causes of neuropathy (e.g., CIDP, trauma, toxins, vitamin deficiencies), advanced renal failure,thyroid disease,chronic alcohol use, pregnancy,
- presence of implanted cardiac devicesthat may interfere with autonomic testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Department of Neurology, Faculty of Medicine,Assiut university
Asyut, Asyut Governorate, 71511
Ahmed Hamed, +201011144391, dahmed.hamed@aun.edu.eg
About this study
Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management.
Read the detailed description
Diabetic peripheral neuropathy (DPN) is a prevalent and disabling complication of diabetes, associated with pain, sensory deficits, gait instability, and increased risk of foot ulcers and amputation. Conventional diagnostic methods, such as nerve conduction studies, primarily identify established disease and may overlook early or autonomic involvement. A multimodal assessment integrating neurophysiological, autonomic, and sonographic techniques offers the potential for earlier detection, improved diagnostic accuracy, and optimized patient management.
- Being tested
- Nerve conduction study, Nerve ultrasound, Autonomic assessment
- Keywords
- Diabete Mellitus, Peripheral neuropathy, Neurophysiological studies, Nerve ultrasound, automatic assessment
- Medical subject headings
- Diabetes Mellitus, Diabetic Neuropathies, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve conduction studyDiagnostic test
Nerve conduction studies (NCS) are widely regarded as the gold standard for evaluating large-fiber peripheral nerve function. They measure conduction velocity, latency, and amplitude, providing objective evidence of axonal loss or demyelination. While highly specific, NCS often detect abnormalities only in established diabetic peripheral neuropathy, limiting their sensitivity for early or subclinical disease.
Nerve ultrasoundDiagnostic test
High-resolution ultrasound (HRUS) is a non-invasive imaging tool that allows structural evaluation of peripheral nerves. It can measure cross-sectional area (CSA), visualize fascicular pattern, and detect nerve enlargement or structural abnormalities. In diabetic peripheral neuropathy, HRUS provides complementary information to functional tests and may identify early or subclinical changes.
Autonomic assessmentDiagnostic test
Autonomic testing provides insight into small-fiber and autonomic nervous system function, often impaired early in diabetic peripheral neuropathy. Heart rate variability (HRV) during deep breathing and postural change is a simple, non-invasive method to detect cardiovascular autonomic dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients with symptomatic peripheral neuropathy. | Other | Not described Receives: Diagnostic Test: Nerve conduction study; Diagnostic Test: Nerve ultrasound |
| Diabetic without any clinical features nor complaints of peripheral neuropathy | Other | Not described Receives: Diagnostic Test: Nerve conduction study; Diagnostic Test: Nerve ultrasound; Diagnostic Test: Autonomic assessment |
| Healthy individuals. | Other | Not described Receives: Diagnostic Test: Nerve conduction study; Diagnostic Test: Nerve ultrasound; Diagnostic Test: Autonomic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of nerve conduction studies for diagnosing diabetic peripheral neuropathy
Percentage of participants with clinically diagnosed diabetic peripheral neuropathy who have abnormal nerve conduction study results (reduced amplitude and/or reduced conduction velocity) at the baseline visit.
Measured: Baseline (single study visit)
Secondary outcomes (1)
Correlation between tibial nerve cross-sectional area and tibial motor conduction velocity
Correlation coefficient between tibial nerve cross-sectional area measured by high-resolution ultrasound and tibial motor nerve conduction velocity at the baseline visit.
Measured: Baseline (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Rageh Daifallah Galal, Assiut University
- Investigators
- Nageh Fouly, Study chair, Department of Neurology , Assiut University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306884
- Sponsor's protocol ID
- 09-2025-200567
- Status last verified
- Dec 2025
- First submitted
- 25 Sep 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological, Autonomic, and Sonographic Assessment of Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07306884
- Acronym / sponsor ID
- 09-2025-200567
- Keywords
- Diabete Mellitus, Peripheral neuropathy, Neurophysiological studies, Nerve ultrasound, automatic assessment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Dec 2025 (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.
Diabetic peripheral neuropathy causes pain, sensory loss, and foot risk; multimodal assessment enables earlier diagnosis and improved patient management.
Detailed description
Diabetic peripheral neuropathy (DPN) is a prevalent and disabling complication of diabetes, associated with pain, sensory deficits, gait instability, and increased risk of foot ulcers and amputation. Conventional diagnostic methods, such as nerve conduction studies, primarily identify established disease and may overlook early or autonomic involvement. A multimodal assessment integrating neurophysiological, autonomic, and sonographic techniques offers the potential for earlier detection, improved diagnostic accuracy, and optimized patient management.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with symptomatic peripheral neuropathy. | Other | Diagnostic Test: Nerve conduction study, Diagnostic Test: Nerve ultrasound |
| Diabetic without any clinical features nor complaints of peripheral neuropathy | Other | Diagnostic Test: Nerve conduction study, Diagnostic Test: Nerve ultrasound, Diagnostic Test: Autonomic assessment |
| Healthy individuals. | Other | Diagnostic Test: Nerve conduction study, Diagnostic Test: Nerve ultrasound, Diagnostic Test: Autonomic assessment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18-75 years with type 1 or type 2 diabetes (with or without diabetic peripheral neuropathy), and age and sex-matched healthy controls
Key exclusion criteria (2 listed)
- Other causes of neuropathy (e.g., CIDP, trauma, toxins, vitamin deficiencies), advanced renal failure,thyroid disease,chronic alcohol use, pregnancy,
- presence of implanted cardiac devicesthat may interfere with autonomic testing
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 |
|---|---|---|
| Nerve conduction studyNerve conduction studies (NCS) are widely regarded as the gold standard for evaluating large-fiber peripheral nerve function. They measure conduction velocity, latency, and amplitude, providing objective evidence of axonal loss or demyelination. While highly specific, NCS often detect abnormalities only in established diabetic peripheral neuropathy, limiting their sensitivity for early or subclinical disease. | Diagnostic test | Diabetic patients with symptomatic peripheral neuropathy., Diabetic without any clinical features nor complaints of peripheral neuropathy, Healthy individuals. |
| Nerve ultrasoundHigh-resolution ultrasound (HRUS) is a non-invasive imaging tool that allows structural evaluation of peripheral nerves. It can measure cross-sectional area (CSA), visualize fascicular pattern, and detect nerve enlargement or structural abnormalities. In diabetic peripheral neuropathy, HRUS provides complementary information to functional tests and may identify early or subclinical changes. | Diagnostic test | Diabetic patients with symptomatic peripheral neuropathy., Diabetic without any clinical features nor complaints of peripheral neuropathy, Healthy individuals. |
| Autonomic assessmentAutonomic testing provides insight into small-fiber and autonomic nervous system function, often impaired early in diabetic peripheral neuropathy. Heart rate variability (HRV) during deep breathing and postural change is a simple, non-invasive method to detect cardiovascular autonomic dysfunction | Diagnostic test | Diabetic without any clinical features nor complaints of peripheral neuropathy, Healthy individuals. |
Primary outcome
Sensitivity of nerve conduction studies for diagnosing diabetic peripheral neuropathy
Time frame: Baseline (single study visit)
Percentage of participants with clinically diagnosed diabetic peripheral neuropathy who have abnormal nerve conduction study results (reduced amplitude and/or reduced conduction velocity) at the baseline visit.
1 secondary outcome
Correlation between tibial nerve cross-sectional area and tibial motor conduction velocity
Time frame: Baseline (single study visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Nageh Fouly study chair
Department of Neurology , Assiut University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve conduction study, Nerve ultrasound and Autonomic assessment in people with Diabete Mellitus and Peripheral (Sensorimotor) Diabetic Polyneuropathy, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia Galal (+201090463145, daliarageh6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of nerve conduction studies for diagnosing diabetic peripheral neuropathy (time frame: Baseline (single study visit)). 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 29 Dec 2025.