An Analysis of Plantar Pressure Distribution and Postural Balance Parameters in Individuals With Diabetic Foot Diagnosis

NCT07084922 — Completed, 32 participants, Medipol University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Association Between Plantar Pressure Distribution and Postural Balance Parameters in Individuals With Diabetic Foot

Registry	NCT07084922
Status	Completed
Study type	Observational
Enrollment	32 (Actual)
Sponsor	Medipol University (Other)
Conditions	Diabetes and Risk of Diabetic Foot Ulcer, Diabetes Mellitus, Postural Control, Plantar Pressure Distrubution
Interventions	No interventions. This is an observational study where participants undergo assessments of plantar pressure and postural balance without any treatment or intervention. (Other)
Dates	start 2025-06-28, primary completion 2025-08-21, completion 2025-08-21, first posted 2025-07-25, last updated 2025-09-19
Locations	1 site in Turkey (Türkiye)

-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. 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.

Expand all sections · Collapse all

+Arms and interventions

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.

+Outcome measures

Primary outcomes

Postural balance assessment [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 [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 [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 \[m²\]

+Eligibility

Sex: All, ages: 40 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Istanbul Medipol University	Istanbul, Istanbul	Turkey (Türkiye)

+Investigators

yağmur uysal, Principal investigator, Medipol University