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Completed

NCT Number: NCT07801131

ULTRASONOGRAPHIC EVALUATION OF TALAR CARTILAGE THICKNESS IN PATIENTS WITH DIABETIC POLYNEUROPATHY

This study aims to evaluate talar cartilage thickness in individuals with diabetic polyneuropathy using ultrasonography and to compare the findings with those of healthy individuals. Diabetic polyneuropathy may induce biomechanical alterations in the lower extremities, which can potentially affect ankle joint structures.

Ultrasonography, a non-invasive and accessible imaging method, will be used to measure cartilage thickness. The study includes individuals with Type 2 diabetes mellitus and electromyography-confirmed diabetic polyneuropathy, as well as age-matched healthy control subjects.

The results are expected to improve understanding of musculoskeletal involvement in diabetic polyneuropathy and to support early detection of joint changes.

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Key information

About this study

This study is designed as a cross-sectional case-control observational study aiming to evaluate talar cartilage thickness in individuals with diabetic polyneuropathy using ultrasonography. Diabetic polyneuropathy is one of the most common chronic complications of diabetes mellitus, characterized by progressive peripheral nerve dysfunction leading to sensory, motor, and autonomic impairments. These impairments result in proprioceptive deficits, reduced muscle strength, and balance disturbances, which collectively alter gait patterns and lower extremity biomechanics.

Such biomechanical alterations may lead to abnormal load distribution across weight-bearing joints, predisposing these structures to progressive degenerative changes. The ankle joint, and particularly the talar cartilage, plays a fundamental role in load transmission and joint congruency. Therefore, it is hypothesized that chronic biomechanical stress and altered loading patterns may contribute to structural changes, including potential thinning or degeneration of the talar cartilage.

Early detection of such alterations may provide valuable insights into musculoskeletal involvement in diabetic polyneuropathy and may contribute to the prevention of progressive joint degeneration. In this context, ultrasonography is increasingly recognized as a non-invasive, radiation-free, reproducible, and cost-effective imaging modality for the assessment of articular cartilage structures.

In this study, ultrasonography will be used to measure talar cartilage thickness according to a standardized and reproducible protocol. The study population will consist of individuals with Type 2 diabetes mellitus and electromyography-confirmed diabetic polyneuropathy, as well as age- and sex-matched healthy control subjects. Talar cartilage thickness will be compared between groups, and potential associations with neuropathy severity, clinical symptom scores, and metabolic parameters will be analyzed.

The findings are expected to contribute to a better understanding of the musculoskeletal manifestations of diabetic polyneuropathy and may support the development of early diagnostic and preventive strategies targeting joint involvement in this patient population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged between 40 and 70 years
  • Individuals diagnosed with type 2 diabetes mellitus for at least 1 year
  • Diagnosis of diabetic polyneuropathy confirmed by electromyography (EMG)
  • No history of trauma or surgery affecting the ankle or foot

Exclusion criteria

  • Presence of degenerative joint disease, rheumatologic disease, or infection affecting the foot or ankle
  • History of trauma or surgical intervention involving the foot or ankle
  • Presence of other systemic diseases that may cause neuropathy
  • Presence of any local skin lesion or deformity that would prevent ultrasonographic assessment

Treatment and study plan

Primary outcomes

  1. Talar Cartilage Thickness

    Time frame: Baseline

    Talar cartilage thickness will be measured using ultrasonography in individuals with diabetic polyneuropathy and healthy control subjects. Measurements will be performed using a standardized protocol, and the mean value of repeated measurements will be recorded for analysis.

Secondary outcomes

  1. Neuropathy Severity Scores (MNSI) Michigan Neuropathy Screening Instrument

    Time frame: Baseline

    Neuropathy severity will be assessed using validated clinical scales including the Michigan Neuropathy Screening Instrument (MNSI)

  2. Glycemic Control (HbA1c Level)

    Time frame: Baseline

    HbA1c levels will be recorded to assess long-term glycemic control in participants.

  3. Body Mass Index (BMI)

    Time frame: Baseline

    Body mass index will be calculated using weight and height measurements (kg/m²)

Other outcomes

  1. LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) questionnaire.)

    Time frame: Baseline

    A total score of 12 or higher indicates a high likelihood of pain with a neuropathic component.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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