Investigation of Ultrasonographic Measurements of Lower Extremity Nerves in Type 2 Diabetes Patients With Peripheral Polyneuropathy
Recruiting · NCT06778005 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
View the official record on ClinicalTrials.gov →Interventions studied
Biodex Balance SystemDouleur Neuropathique 4 (DN4) Pain ScaleInternational Physical Activity Questionnaire-Short Form (IPAQ)Numeric Rating ScalePhysical ExaminationSF-12 Quality of Life ScaleSix-Minute Walk TestTimed Up and Go TestToronto Clinical Neuropathy ScoreTuning Fork Vibration SenseUltrasonography
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
2 locations listed.
- Sultan 2. Abdulhamid Han Training and Research Hospital - Istanbul, Üsküdar, Turkey (Türkiye)
- Sultan 2. Abdulhamid Han Training and Research Hospital - Istanbul, Üsküdar, Turkey (Türkiye)