Diabetic Peripheral Neuropathy (DPN)NCT06773793
The Diagnostic Value of Shear Wave Elastography and Viscosity Imaging Techniques in Diabetic Peripheral Neuropathy
An observational study of Diabetic Peripheral Neuropathy (DPN), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.
Trial summary
The main objective of this observational study is to evaluate the diagnostic value of multimodal ultrasound for diabetic peripheral neuropathy (DPN). The questions it aims to address are: (1) To compare the differences in various parameters between the DPN group, non-DPN group, and healthy control group; (2) To… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- 7 Apr 2024to Mar 2029
- Phase
- Observational
- 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
Study population: Clinically diagnosed type 2 diabetes patients, aged 18 to 75 years, without neuropathy caused by other diseases or factors
Inclusion Criteria:Individuals aged 18 to 75 years without diabetes -
Exclusion Criteria:Individuals without peripheral neuropathy.
-
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210031
About this study
The main objective of this observational study is to evaluate the diagnostic value of multimodal ultrasound for diabetic peripheral neuropathy (DPN). The questions it aims to address are: (1) To compare the differences in various parameters between the DPN group, non-DPN group, and healthy control group; (2) To explore the diagnostic efficacy of each parameter for DPN and establish a combined model.
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Wave Velocity
Measured: from 2024-4 to 2029-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start7 Apr 2024
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. weijing zhang, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773793
- Sponsor's protocol ID
- NDTHNanjingUMS.
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Shear Wave Elastography and Viscosity Imaging Techniques in Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06773793
- Acronym / sponsor ID
- NDTHNanjingUMS.
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 14 Jan 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.
The main objective of this observational study is to evaluate the diagnostic value of multimodal ultrasound for diabetic peripheral neuropathy (DPN). The questions it aims to address are: (1) To compare the differences in various parameters between the DPN group, non-DPN group, and healthy control group; (2) To explore the diagnostic efficacy of each parameter for DPN and establish a combined model.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically diagnosed type 2 diabetes patients, aged 18 to 75 years, without neuropathy caused by other diseases or factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shear Wave Velocity
Time frame: from 2024-4 to 2029-4
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 14 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy (DPN), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Wave Velocity (time frame: from 2024-4 to 2029-4). 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 14 Jan 2025.