Diabetic Peripheral NeuropathyNCT02308059
Ultrasonographic Evaluation of Diabetic Neuropathy
An observational study of Diabetic Peripheral Neuropathy, run by Cukurova University.
Trial summary
The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with clinical and demographic data. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Ultrasonographic evaluation of nerves in diabetic patients and Ultrasonographic evaluation of nerves of healthy volunteers
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Dec 2014
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients in a University Hospital
Who may be able to join
- type 2 diabetes mellitus
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores ≥ 12
- probable diabetic peripheral neuropathy according to the diabetic peripheral neuropathy criteria.
Who cannot join
- type 1 diabetes mellitus
- hypothyroidism
- LANSS pain scale scores < 12
- body mass index (BMI) > 35
- current pregnancy
- histories of hereditary neuropathy, inflammatory neuropathy, nerve trauma, or other known causes of polyneuropathy; and the use of anti-neuropathic drugs.
About this study
Official title: Diabetic Peripheral Neuropathy: Correlation Between Ultrasound Findings and Clinical Features
The current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with clinical and demographic data.
Read the detailed description
Patients with diabetic peripheral neuropathy (n=53) and a matched healthy control group (n=53) underwent blinded ultrasonography imaging of the sciatic, tibial and median nerves. Matching was performed according to patient body mass index (BMI), sex and age. CSAs of the nerves were recorded, and the associations between pain intensity (measured with a visual analog scale [VAS]), the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, diabetes mellitus duration, BMI, HbA1c and blood glucose levels were evaluated.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Ultrasonographic evaluation of nerves in diabetic patients, Ultrasonographic evaluation of nerves of healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic evaluation of nerves in diabetic patientsOther
Also called ultasonographic evaluation
Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy
Ultrasonographic evaluation of nerves of healthy volunteersOther
evaluation of peripheral nerves and correlated with group I
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes mellitus | Group I; the patients with diabetes mellitus who had peripheral neuropathy as diagnosed. Receives: Other: Ultrasonographic evaluation of nerves in diabetic patients | |
| Control | Group II; healthy volunteers Receives: Other: Ultrasonographic evaluation of nerves of healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on the visual analog scale
Measured: 3 years
Secondary outcomes (1)
Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bayram Kelle, Cukurova University
- Investigators
- Bayram Kelle, Principal investigator, Çukurova University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308059
- Sponsor's protocol ID
- TF2012BAP13
- Status last verified
- Dec 2014
- First submitted
- 1 Dec 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Peripheral Neuropathy: Correlation Between Ultrasound Findings and Clinical Features
- ClinicalTrials.gov ID
- NCT02308059
- Acronym / sponsor ID
- TF2012BAP13
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Dec 2014 (estimated)
- 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 current study aimed to evaluate the cross-sectional area (CSA) of peripheral nerves in people with diabetic peripheral neuropathy using ultrasonography and correlate the CSA with clinical and demographic data.
Detailed description
Patients with diabetic peripheral neuropathy (n=53) and a matched healthy control group (n=53) underwent blinded ultrasonography imaging of the sciatic, tibial and median nerves. Matching was performed according to patient body mass index (BMI), sex and age. CSAs of the nerves were recorded, and the associations between pain intensity (measured with a visual analog scale [VAS]), the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale, diabetes mellitus duration, BMI, HbA1c and blood glucose levels were evaluated.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes mellitus | – | Other: Ultrasonographic evaluation of nerves in diabetic patientsGroup I; the patients with diabetes mellitus who had peripheral neuropathy as diagnosed. |
| Control | – | Other: Ultrasonographic evaluation of nerves of healthy volunteersGroup II; healthy volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients in a University Hospital
Key inclusion criteria (3 listed)
- type 2 diabetes mellitus
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores ≥ 12
- probable diabetic peripheral neuropathy according to the diabetic peripheral neuropathy criteria.
Key exclusion criteria (6 listed)
- type 1 diabetes mellitus
- hypothyroidism
- LANSS pain scale scores < 12
- body mass index (BMI) > 35
- current pregnancy
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 |
|---|---|---|
| Ultrasonographic evaluation of nerves in diabetic patientsAlso: ultasonographic evaluationUltrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy | Other | Patients with diabetes mellitus |
| Ultrasonographic evaluation of nerves of healthy volunteersevaluation of peripheral nerves and correlated with group I | Other | Control |
Primary outcome
Pain scores on the visual analog scale
Time frame: 3 years
1 secondary outcome
Neuropathic pain scores on the Leeds Assessment of Neuropathic Symptoms and Signs pain scale
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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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.
Bayram Kelle principal investigator
Çukurova University, Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy, run by Cukurova University.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 4 Dec 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain scores on the visual analog scale (time frame: 3 years). 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 4 Dec 2014.