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ULTRASONOGRAPHIC EVALUATION OF TALAR CARTILAGE THICKNESS IN PATIENTS WITH DIABETIC POLYNEUROPATHY

ULTRASONOGRAPHIC EVALUATION OF TALAR CARTILAGE THICKNESS IN PATIENTS WITH DIABETIC POLYNEUROPATHY

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07801131
Enrollment
30
Registered
2026-09-03
Start date
2026-06-19
Completion date
2026-07-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Joint, Diabetic Polyneuropathy, Talar Cartilage Thickness, Type 2 Diabetes Mellitus, Type 2 Diabetes Mellitus With Diabetic Nephropathy, Ultrasonography

Keywords

Ultrasonography, Diabetic Polyneuropathy, Talar Cartilage, Ankle Joint, Cartilage Thickness, Type 2 Diabetes Mellitus, Peripheral Neuropathy, Lower Extremity Biomechanics

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Talar Cartilage ThicknessBaselineTalar 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

MeasureTime frameDescription
Neuropathy Severity Scores (MNSI) Michigan Neuropathy Screening InstrumentBaselineNeuropathy severity will be assessed using validated clinical scales including the Michigan Neuropathy Screening Instrument (MNSI)
Glycemic Control (HbA1c Level)BaselineHbA1c levels will be recorded to assess long-term glycemic control in participants.
Body Mass Index (BMI)BaselineBody mass index will be calculated using weight and height measurements (kg/m²)

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORAybike Ata, Medical Doctor

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

STUDY_DIRECTORKadriye Oneş, Professor

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

STUDY_DIRECTORSelim Sezikli, Specialist doctor

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026