NCT06778005 Investigation of Ultrasonographic Measurements of Lower Extremity Nerves in Type 2 Diabetes Patients With Peripheral Polyneuropathy
| NCT ID | NCT06778005 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
| Condition | Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 86 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 86 participants in total. It began in 2025-01-01 with a primary completion date of 2025-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to quantitatively evaluate ultrasonographic measurements of the lower extremity nerves in patients diagnosed with diabetic polyneuropathy and to investigate the relationship with gait, static and dynamic balance performance. In this study, we aimed to investigate the effect of ultrasonographic findings of lower extremity nerves on quality of daily life, physical activity, gait and balance in patients with diabetic peripheral polyneuropathy.
Eligibility 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
Contact & Investigator
Emre Ata, Ass. Prof.
STUDY DIRECTOR
Sultan 2. Abdulhamid Han Training and Research Hospital
Frequently Asked Questions
Who can join the NCT06778005 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06778005 currently recruiting?
Yes, NCT06778005 is actively recruiting participants. Contact the research team at semihaozguc@hotmail.com for enrollment information.
Where is the NCT06778005 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye), Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06778005 clinical trial?
NCT06778005 is sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. The principal investigator is Emre Ata, Ass. Prof. at Sultan 2. Abdulhamid Han Training and Research Hospital. The trial plans to enroll 86 participants.
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