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

NCT07084922 | Completed

• 1 other identifier: MedipolU-OPZ-YU-02
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes and Risk of Diabetic Foot Ulcer; Diabetes Mellitus; Postural Control; Plantar Pressure Distrubution

Keywords

Postural Control; Diabetic Foot; Plantar Pressure; Plantar Loading

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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 \[m²\]

  first day of study

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.

Eligibility Criteria

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

Study Population

Diagnosed with diabetic foot

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, 34794, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Interventions

Postural Balance; Methods

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Proprioception; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Investigative Techniques

Study Officials

• yağmur uysal

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 25, 2025
• Study Start: June 28, 2025
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)