Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06778005

Investigation of the Relationship of Ultrasonographic Measurements of Lower Extremity Nerves With Gait and Balance Performance in Type 2 Diabetes Patients With Peripheral Polyneuropathy

Led by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Updated on 2025-09-12

86

Participants Needed

2

Research Sites

11 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how ultrasonographic measurements of the lower extremity nerves relate to walking ability and balance in adults with type 2 diabetes who have peripheral polyneuropathy. This study aims to understand how these nerve changes impact daily life, physical activity, gait, and balance. Diabetic neuropathy is a common complication that affects nerve function and quality of life, and early detection using ultrasonography could improve patient care. The study involves two groups: healthy volunteers and patients with diabetic peripheral polyneuropathy. Participants will undergo ultrasonographic nerve assessments using a specialized ultrasound device. Additional evaluations include balance testing with the Biodex Balance System, neuropathic pain scales, physical performance tests such as the six-minute walk test and Timed Up and Go Test, as well as quality of life and physical activity questionnaires. All measurements and tests will occur once during the study period. Participants will have a single evaluation session where demographic and clinical data are collected, including blood tests and neuropathy assessments. The study measures include ultrasonography, balance, pain scales, nerve function scores, walking tests, and quality of life surveys. The research will analyze these outcomes to better understand nerve changes and their effects on balance and gait in diabetic polyneuropathy. The study is planned between December 2024 and May 2025 with a total of 86 participants.

CONDITIONS

Brief Title

Investigation of Ultrasonographic Measurements of Lower Extremity Nerves in Type 2 Diabetes Patients With Peripheral Polyneuropathy

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Group 1: Age between 18 and 65 years
  • Group 1: Able to read and write
  • Group 1: Signed voluntary consent to participate
  • Group 2: Diagnosed with Type 2 Diabetes based on standard criteria
  • Group 2: Diagnosed with diabetic peripheral polyneuropathy confirmed by EMG
  • Group 2: Age between 18 and 65 years
  • Group 2: Able to read and write
  • Group 2: Signed voluntary consent to participate
Not Eligible

You will not qualify if you...

  • Age under 18 or over 65 years
  • Diagnosed with Type 1 diabetes
  • Use of medications that can cause polyneuropathy
  • Other causes of neuropathic pain (e.g., lumbar radiculopathy, spinal stenosis, hereditary or inflammatory neuropathies)
  • Underwent lower extremity surgery in the last 6 months
  • Peripheral artery disease
  • Vitamin B12 deficiency
  • Active foot ulcer
  • History of lower extremity amputation
  • Severe cardiopulmonary insufficiency (stage 3-4)
  • Myocardial infarction within the last 1 month
  • Unstable angina
  • Active systemic inflammatory diseases or active cancer
  • Vestibular disorders
  • Cognitive impairment
  • Osteoarthritis in lower extremity
  • Pregnancy
  • Body Mass Index (BMI) of 30 or higher

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo a comprehensive assessment including ultrasonography of lower extremity nerves, balance and gait performance tests, pain and neuropathy scales, physical examination, and functional capacity tests to evaluate diabetic peripheral polyneuropathy and overall nerve function.

1 visit (in-person)

Trial Site Locations

Total: 2 locations

1

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye), 34674

Active, Not Recruiting

2

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Üsküdar, Turkey (Türkiye)

Actively Recruiting

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Research Team

S

Semiha Özgüç

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Cross-sectional area reference values for peripheral nerve ultrasound in adults: A systematic review and meta-analysis-Part II: Lower extremity nerves.

Anna Lena Fisse, Aristeidis H Katsanos, Ralf Gold...

https://pubmed.ncbi.nlm.nih.gov/33794049