Diabetes and Risk of Diabetic Foot UlcerNCT07084922
An Analysis of Plantar Pressure Distribution and Postural Balance Parameters in Individuals With Diabetic Foot Diagnosis
An observational study of Diabetes and Risk of Diabetic Foot Ulcer and Diabetes Mellitus, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the relationship between plantar pressure distribution and postural balance in individuals diagnosed with diabetic foot. Diabetic foot is a common and serious complication of diabetes that increases the risk of foot ulcers and falls. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes and Risk of Diabetic Foot Ulcer, Diabetes Mellitus, Postural Control
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2025to 21 Aug 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnosed with diabetic foot
Who may be able to join
- Adults aged between 40 and 65 years
- Diagnosed with diabetic foot at Stage 0 or Stage 1 according to the Meggitt-Wagner classification
- No history of foot or ankle surgery
- Able to walk independently without assistive devices
- Clinically assessed as at risk for diabetic foot
Who cannot join
- History of amputation in the foot or ankle
- Previous foot or ankle surgery
- Use of medications affecting balance or gait
- Presence of any neurological or musculoskeletal disorder unrelated to diabetic foot that affects mobility or balance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Istanbul, 34794
About this study
Official title: Association Between Plantar Pressure Distribution and Postural Balance Parameters in Individuals With Diabetic Foot
This study aims to investigate the relationship between plantar pressure distribution and postural balance in individuals diagnosed with diabetic foot. Diabetic foot is a common and serious complication of diabetes that increases the risk of foot ulcers and falls. Due to nerve damage and changes in walking biomechanics, individuals with diabetic foot may experience abnormal pressure on the soles of their feet and poor balance.
The study includes 32 participants aged 40-65 years who have been clinically diagnosed with diabetic foot (Stage 0 or 1 according to the Meggitt-Wagner classification). Participants undergo plantar pressure assessment using a pedobarographic system and balance testing using a Wii Balance Board system under different standing conditions (eyes open/closed, single/double leg stance). The study aims to identify high-risk plantar regions and impaired balance patterns to guide early interventions, reduce ulcer risk, and prevent falls.
- Conditions
- Diabetes and Risk of Diabetic Foot Ulcer, Diabetes Mellitus, Postural Control, Plantar Pressure Distrubution
- Being tested
- No interventions. This is an observational study where participants undergo assessments of plantar pressure and postural balance without any treatment or intervention.
- Keywords
- Postural Control, Diabetic Foot, Plantar Pressure, Plantar Loading
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions. This is an observational study where participants undergo assessments of plantar pressure and postural balance without any treatment or intervention.Other
No interventions. This is an observational study where participants undergo assessments of plantar pressure and postural balance without any treatment or intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural balance assessment
Postural balance assessment in the study will be performed with 'Becure Balance System (Becure Global GmbH)'. Individuals will be evaluated for balance on the device with eyes open-closed, single foot-double foot.
Measured: first day of the study
Pedobarographic analysis
Pedobarographic analysis and evaluation of postural balance are widely used by clinicians and researchers to examine the foot structure and to determine the loading patterns of the foot. The data are obtained with electronic sensors placed on the platform where the gait takes place. The sensors are directly connected to the platforms and the computer system programmed to perform foot analysis. With the pedobarography device, pressure distribution data in the foot are obtained in static condition. Foot plantar pressure analysis will be performed using the EsCoSCAN® static pedobarographic assessment device. During the analysis, the individual will be made to stand without moving while looking straight ahead in the standing position for static analysis.
Measured: first day of the study
Demographic Information Form
The patient's demographic information, including height, weight, age, and diabetes type (Type 1 or Type 2), will be recorded using this form. Body Mass Index (BMI) will be calculated based on the recorded height and weight data (BMI = weight [kg] / height² [m²]
Measured: first day of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start28 Jun 2025
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes and Risk of Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur UYSAL, Medipol University
- Investigators
- yağmur uysal, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084922
- Sponsor's protocol ID
- MedipolU-OPZ-YU-02
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not sure
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Plantar Pressure Distribution and Postural Balance Parameters in Individuals With Diabetic Foot
- ClinicalTrials.gov ID
- NCT07084922
- Acronym / sponsor ID
- MedipolU-OPZ-YU-02
- Conditions
- Diabetes and Risk of Diabetic Foot Ulcer, Diabetes Mellitus, Postural Control, Plantar Pressure Distrubution
- Keywords
- Postural Control, Diabetic Foot, Plantar Pressure, Plantar Loading
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 28 Jun 2025 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 25 Jul 2025 (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 aims to investigate the relationship between plantar pressure distribution and postural balance in individuals diagnosed with diabetic foot. Diabetic foot is a common and serious complication of diabetes that increases the risk of foot ulcers and falls. Due to nerve damage and changes in walking biomechanics, individuals with diabetic foot may experience abnormal pressure on the soles of their feet and poor balance.
The study includes 32 participants aged 40-65 years who have been clinically diagnosed with diabetic foot (Stage 0 or 1 according to the Meggitt-Wagner classification). Participants undergo plantar pressure assessment using a pedobarographic system and balance testing using a Wii Balance Board system under different standing conditions (eyes open/closed, single/double leg stance). The study aims to identify high-risk plantar regions and impaired balance patterns to guide early interventions, reduce ulcer risk, and prevent falls.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with diabetic foot
Key inclusion criteria (5 listed)
- Adults aged between 40 and 65 years
- Diagnosed with diabetic foot at Stage 0 or Stage 1 according to the Meggitt-Wagner classification
- No history of foot or ankle surgery
- Able to walk independently without assistive devices
- Clinically assessed as at risk for diabetic foot
Key exclusion criteria (4 listed)
- History of amputation in the foot or ankle
- Previous foot or ankle surgery
- Use of medications affecting balance or gait
- Presence of any neurological or musculoskeletal disorder unrelated to diabetic foot that affects mobility or balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions. This is an observational study where participants undergo assessments of plantar pressure and postural balance without any treatment or intervention.No interventions. This is an observational study where participants undergo assessments of plantar pressure and postural balance without any treatment or intervention. | Other | – |
Primary outcome
Postural balance assessment
Time frame: first day of the study
Postural balance assessment in the study will be performed with 'Becure Balance System (Becure Global GmbH)'. Individuals will be evaluated for balance on the device with eyes open-closed, single foot-double foot.
Pedobarographic analysis
Time frame: first day of the study
Pedobarographic analysis and evaluation of postural balance are widely used by clinicians and researchers to examine the foot structure and to determine the loading patterns of the foot. The data are obtained with electronic sensors placed on the platform where the gait takes place. The sensors are directly connected to the platforms and the computer system programmed to perform foot analysis. With the pedobarography device, pressure distribution data in the foot are obtained in static condition. Foot plantar pressure analysis will be performed using the EsCoSCAN® static pedobarographic assessment device. During the analysis, the individual will be made to stand without moving while looking straight ahead in the standing position for static analysis.
Demographic Information Form
Time frame: first day of study
The patient's demographic information, including height, weight, age, and diabetes type (Type 1 or Type 2), will be recorded using this form. Body Mass Index (BMI) will be calculated based on the recorded height and weight data (BMI = weight [kg] / height² [m²]
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 19 Sep 2025.
- Individual participant dataSharing planned: No. not sure
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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.
yağmur uysal principal investigator
Medipol University
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 Diabetes and Risk of Diabetic Foot Ulcer and Diabetes Mellitus, run by Medipol University 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 5 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 19 Sep 2025. 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?
Postural balance assessment (time frame: first day of the study). The study lists 3 primary outcomes in all. 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 19 Sep 2025.