Type 2 Diabetes MellitusNCT07801131
Ultrasonographic Evaluation of Talar Cartilage Thickness in Patients With Diabetic Polyneuropathy
An observational study of Type 2 Diabetes Mellitus and Diabetic Polyneuropathy, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed 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 cause biomechanical changes in the lower extremities, which may affect ankle joint structures. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Polyneuropathy
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included two groups aged 40-70 years: patients with type 2 diabetes mellitus and EMG-confirmed diabetic polyneuropathy, and sex-matched healthy volunteers without diabetes or neuropathy. Participants were recruited from the Physical Medicine and Rehabilitation outpatient clinic.
Who may be able to join
- Age 40-70 years
- Type 2 diabetes mellitus for at least 1 year
- Diabetic polyneuropathy confirmed by electromyography (EMG)
- Age 40-70 years
- No diagnosis of diabetes mellitus and fasting plasma glucose <126 mg/dL
- No symptoms or signs of neuropathy (Michigan Neuropathy Screening Instrument)
Who cannot join
- History of trauma or surgery involving the foot or ankle
- Degenerative joint disease, rheumatologic disease or infection of the foot or ankle
- Local skin lesion or deformity preventing ultrasonographic assessment
- Other systemic diseases that may cause neuropathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, bahçelievler, 34180
About this study
This study aimed 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 cause biomechanical changes in the lower extremities, which may affect ankle joint structures.
Ultrasonography, a non-invasive and accessible imaging method, was used to measure cartilage thickness. The study included individuals with type 2 diabetes mellitus and electromyography-confirmed diabetic polyneuropathy, as well as sex-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.
Read the detailed description
This cross-sectional case-control observational study aimed 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. It is 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 together alter gait patterns and lower extremity biomechanics.
Such biomechanical changes may lead to abnormal load distribution across weight-bearing joints and predispose these structures to degenerative changes. The ankle joint, and particularly the talar cartilage, plays a key role in load transmission. Therefore, it was hypothesized that talar cartilage would be thinner in individuals with diabetic polyneuropathy than in healthy controls.
Ultrasonography is a non-invasive, radiation-free and low-cost imaging method for assessing articular cartilage. In this study, talar cartilage thickness was measured bilaterally using a standardized protocol. The study population consisted of individuals with type 2 diabetes mellitus and electromyography-confirmed diabetic polyneuropathy, and sex-matched healthy control subjects. Talar cartilage thickness was compared between groups. Its associations with glycemic control, diabetes and neuropathy duration, neuropathy severity and neuropathic pain scores were also analyzed in the patient group.
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Polyneuropathy
- Keywords
- Ultrasonography, Diabetic Polyneuropathy, Talar Cartilage, Ankle Joint, Cartilage Thickness, Type 2 Diabetes Mellitus, Peripheral Neuropathy, Lower Extremity Biomechanics
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1- Diabetic Polyneuropathy Group | Individuals with type 2 diabetes mellitus and electromyography-confirmed diabetic polyneuropathy. Participants underwent ultrasonographic measurement of talar cartilage thickness. | |
| 2-Healthy Control Group | Sex-matched healthy individuals without diabetes mellitus or peripheral neuropathy. Participants underwent ultrasonographic measurement of talar cartilage thickness using the same protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Talar Cartilage Thickness
Talar cartilage thickness (mm) was measured bilaterally by ultrasonography from the anterior ankle in individuals with diabetic polyneuropathy and healthy control subjects. Three measurements were taken for each ankle and averaged.
Measured: Baseline
Secondary outcomes (2)
Neuropathy Severity Scores (MNSI) Michigan Neuropathy Screening Instrument
Neuropathy was assessed with the Turkish version of the Michigan Neuropathy Screening Instrument, including a 15-item questionnaire (maximum 13 points) and a physical examination (maximum 8 points). Higher scores indicate more severe neuropathy.
Measured: Baseline
Glycemic Control (HbA1c Level)
HbA1c levels measured within the last three months were obtained from hospital records to assess long-term glycemic control.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jul 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aybike Ata, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Aybike Ata, Medical Doctor, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research HospitalKadriye Öneş, Professor, Study chair, Istanbul Physical Medicine Rehabilitation Training and Research HospitalSelim Sezikli, Medical doctor, Study director, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801131
- Sponsor's protocol ID
- IstanbulPMRTRH2025-42
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared to protect participant confidentiality and comply with ethical and institutional data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Talar Cartilage Thickness in Patients With Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT07801131
- Acronym / sponsor ID
- IstanbulPMRTRH2025-42
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Polyneuropathy
- Keywords
- Ultrasonography, Diabetic Polyneuropathy, Talar Cartilage, Ankle Joint, Cartilage Thickness, Type 2 Diabetes Mellitus, Peripheral Neuropathy, Lower Extremity Biomechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed 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 cause biomechanical changes in the lower extremities, which may affect ankle joint structures.
Ultrasonography, a non-invasive and accessible imaging method, was used to measure cartilage thickness. The study included individuals with type 2 diabetes mellitus and electromyography-confirmed diabetic polyneuropathy, as well as sex-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 cross-sectional case-control observational study aimed 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. It is 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 together alter gait patterns and lower extremity biomechanics.
Such biomechanical changes may lead to abnormal load distribution across weight-bearing joints and predispose these structures to degenerative changes. The ankle joint, and particularly the talar cartilage, plays a key role in load transmission. Therefore, it was hypothesized that talar cartilage would be thinner in individuals with diabetic polyneuropathy than in healthy controls.
Ultrasonography is a non-invasive, radiation-free and low-cost imaging method for assessing articular cartilage. In this study, talar cartilage thickness was measured bilaterally using a standardized protocol. The study population consisted of individuals with type 2 diabetes mellitus and electromyography-confirmed diabetic polyneuropathy, and sex-matched healthy control subjects. Talar cartilage thickness was compared between groups. Its associations with glycemic control, diabetes and neuropathy duration, neuropathy severity and neuropathic pain scores were also analyzed in the patient group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- Diabetic Polyneuropathy Group | – | –Individuals with type 2 diabetes mellitus and electromyography-confirmed diabetic polyneuropathy. Participants underwent ultrasonographic measurement of talar cartilage thickness. |
| 2-Healthy Control Group | – | –Sex-matched healthy individuals without diabetes mellitus or peripheral neuropathy. Participants underwent ultrasonographic measurement of talar cartilage thickness using the same protocol. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included two groups aged 40-70 years: patients with type 2 diabetes mellitus and EMG-confirmed diabetic polyneuropathy, and sex-matched healthy volunteers without diabetes or neuropathy. Participants were recruited from the Physical Medicine and Rehabilitation outpatient clinic.
Key inclusion criteria (6 listed)
- Age 40-70 years
- Type 2 diabetes mellitus for at least 1 year
- Diabetic polyneuropathy confirmed by electromyography (EMG)
- Age 40-70 years
- No diagnosis of diabetes mellitus and fasting plasma glucose <126 mg/dL
Key exclusion criteria (4 listed)
- History of trauma or surgery involving the foot or ankle
- Degenerative joint disease, rheumatologic disease or infection of the foot or ankle
- Local skin lesion or deformity preventing ultrasonographic assessment
- Other systemic diseases that may cause neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Talar Cartilage Thickness
Time frame: Baseline
Talar cartilage thickness (mm) was measured bilaterally by ultrasonography from the anterior ankle in individuals with diabetic polyneuropathy and healthy control subjects. Three measurements were taken for each ankle and averaged.
2 secondary outcomes
Neuropathy Severity Scores (MNSI) Michigan Neuropathy Screening Instrument
Time frame: Baseline
Glycemic Control (HbA1c Level)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual patient data will not be shared to protect participant confidentiality and comply with ethical and institutional data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aybike Ata, Medical Doctor principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Kadriye Öneş, Professor study chair
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Selim Sezikli, Medical doctor study director
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Diabetic Polyneuropathy, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Talar Cartilage Thickness (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.