ULTRASONOGRAPHIC EVALUATION OF TALAR CARTILAGE THICKNESS IN PATIENTS WITH DIABETIC POLYNEUROPATHY

NCT07801131 | Completed

• 1 other identifier: IstanbulPMRTRH2025-42
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Talar Cartilage Thickness

  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.

  Baseline

Secondary Outcomes (3)

• Neuropathy Severity Scores (MNSI) Michigan Neuropathy Screening Instrument

  Baseline

• Glycemic Control (HbA1c Level)

  Baseline

• Body Mass Index (BMI)

  Baseline

Other Outcomes (1)

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

  Baseline

Study Arms (2)

1- Diabetic Polyneuropathy Group

Group 1 (Diabetic Polyneuropathy Group) This group will include individuals with Type 2 diabetes mellitus and electromyography-confirmed diabetic polyneuropathy. Participants will undergo ultrasonographic measurement of talar cartilage thickness.

2-Healthy Control Group

Group 2 (Healthy Control Group) This group will include age- and sex-matched healthy individuals without diabetes mellitus or peripheral neuropathy. Participants will undergo ultrasonographic measurement of talar cartilage thickness under the same standardized protocol.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of individuals aged 40-70 years diagnosed with type 2 diabetes mellitus for at least one year. Participants will include patients with electromyography (EMG)-confirmed diabetic polyneuropathy and no history of trauma or surgical intervention affecting the foot or ankle. Individuals with degenerative, rheumatologic, or infectious conditions of the lower extremity, as well as those with other systemic causes of neuropathy or skin conditions preventing ultrasonographic assessment, will be excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istabul Physical Medicine and Rehabilitation Hospital

Istanbul, bahçelievler, 34180, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Neuropathies; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Study Officials

• Aybike Ata, Medical Doctor

  Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Kadriye Oneş, Professor

  Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

  STUDY DIRECTOR

• Selim Sezikli, Specialist doctor

  Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Assistant Doctor / Researcher)

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 3, 2026
• Study Start: June 19, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)