Ultrasound of leg nerves linked to walking and balance in adults with type 2 diabetes
Investigation of the Relationship of Ultrasonographic Measurements of Lower Extremity Nerves With Gait and Balance Performance in Type 2 Diabetes Patients With Peripheral Polyneuropathy
The study will use ultrasound to measure lower-leg nerves and see if nerve changes relate to walking, balance, pain, and daily activity in adults with type 2 diabetes and peripheral neuropathy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey Academic / other |
| Locations | 2 sites (Istanbul, Üsküdar and 1 other locations) |
| Trial ID | NCT06778005 on ClinicalTrials.gov |
What this trial studies
This observational, single-center study enrolls adults 18–65 with type 2 diabetes and EMG-confirmed peripheral polyneuropathy alongside literate control participants to compare nerve imaging and function. High-resolution ultrasonography will measure lower-extremity nerve structure while standardized tests—Biodex balance system, gait assessments, DN4, numeric pain ratings, and the Toronto Clinical Neuropathy Score—quantify balance, gait, pain, and neuropathy severity. Investigators will analyze correlations between sonographic findings and functional measures to determine whether ultrasound changes track with gait impairment, balance deficits, and reduced daily activity. All imaging and performance testing are performed in person at the study hospital in Istanbul.
Who should consider this trial
Good fit: Ideal candidates are literate adults aged 18–65 with type 2 diabetes and EMG-confirmed peripheral polyneuropathy who can attend in-person visits at the Istanbul site, with similar-age healthy literate adults considered for comparison.
Not a fit: People with type 1 diabetes, neuropathy from other non-diabetic causes, those on medications known to cause neuropathy, or individuals outside the 18–65 age range are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this approach could make it easier and more comfortable to detect diabetic nerve damage early and link structural changes to balance and mobility problems.
How similar studies have performed: Prior studies have shown ultrasound can detect nerve enlargement and other structural changes in diabetic neuropathy with promising correlations to clinical severity, but it has not yet replaced nerve conduction studies for routine diagnosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (Group 1): * Being between the ages of 18-65 * Being literate * Signed a voluntary consent form agreeing to participate in the study Inclusion Criteria (Group 2): * Diagnosed with Type 2 Diabetes based on at least one of the following diagnostic criteria: fasting plasma glucose ≥ 126 mg/dl, 2-hour plasma glucose ≥ 200 mg/dl in an oral glucose tolerance test, HbA1c ≥ 6.5%, or diabetes symptoms (excessive thirst, eating, urination, and weight loss) + random plasma glucose ≥ 200 mg/dl. (14) * Diagnosed with diabetic peripheral polyneuropathy through EMG evaluation in addition to Type 2 Diabetes. * Being between the ages of 18-65 * Being literate * Signed a voluntary consent form agreeing to participate in the study. Exclusion Criteria: * Individuals under 18 years old and over 65 years old * Diagnosed with Type 1 diabetes * Use of medications that can cause polyneuropathy * Other causes of neuropathic pain (lumbar radiculopathy, spinal stenosis, -hereditary, inflammatory, entrapment neuropathies) * Undergoing lower extremity surgery (spine/hip/knee/foot) in the last 6 months * Having peripheral artery disease * B12 vitamin deficiency * Active foot ulcer * History of lower extremity amputation * Severe cardiopulmonary insufficiency (stage 3-4) * History of myocardial infarction within the last 1 month * History of unstable angina * Active systemic inflammatory diseases and active malignancy * Presence of vestibular disorders * Presence of cognitive impairment * Osteoarthritis in the lower extremity * Pregnancy * Body Mass Index (BMI) of 30 or higher
Where this trial is running
Istanbul, Üsküdar and 1 other locations
- Sultan 2. Abdulhamid Han Training and Research Hospital — Istanbul, Üsküdar, Turkey (Türkiye) (Active_not_recruiting)
- Sultan 2. Abdulhamid Han Training and Research Hospital — Istanbul, Üsküdar, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Semiha Özgüç, M.D. — Sultan 2. Abdulhamid Han Training and Research Hospital
- Study coordinator: Semiha Özgüç
- Email: semihaozguc@hotmail.com
- Phone: 5426311029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.