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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes and Risk of Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Plantar Pressure Distrubution Postural Control Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University

Istanbul, 34794, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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]

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 25, 2025
Registry last updated: Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed