The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters

Not Applicable

Active, not recruiting

• Conditions: Diabetic Foot Ulcer (DFU); Orthoses; Postural Balance; Plantar Pressure Distrubution

• Registration Number: NCT06846476
• Lead Sponsor: Medipol University

Brief Summary

Postural control and plantar pressure are affected by many parameters in diabetic individuals. It is considered important to examine the relationship between changes in plantar pressure distribution and postural balance, physiological expenditure index and gait parameters in diabetic individuals. Within the scope of this project, based on the above mentioned reasons, we plan to produce a personalised off loading insoles designed for diabetic foot.

Detailed Description

Excessive localized loading on the plantar surface leads to repeated microtrauma and the development of diabetic foot ulcers. The plantar region, subjected to constant weight-bearing pressure, develops chronic wounds due to dangerous vascularity. Excessive plantar pressure is considered the primary risk factor for plantar ulcers in diabetic individuals; custom insoles are considered the gold standard in treatment for off-loading plantar pressure.

The off-loading technique, which reduces plantar pressure, is an effective ulcer prevention strategy for neuropathic feet with impaired sensation and increased plantar load and tissue stress.

A review of the literature shows that previous studies have clearly demonstrated that off-loading insoles are effective in reducing abnormal plantar pressure in a specific area and that they also have some effect on the pressure distribution in surrounding areas. However, the potential impact of this positive effect on postural balance, postural control, and individuals' physiological expenditure and energy consumption has not been sufficiently studied.

Therefore, it is considered important to investigate the relationship between changes in plantar pressure distribution, postural balance, physiological expenditure index, and walking parameters in diabetic individuals.

Study Timeline

• Study Start: 2024-12-24
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-26
• Primary Completion: 2025-05-08
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-08
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• between the ages of 40 and 65,
• Wagner Classification stages 0 or 1,
• He has type I or type II diabetes,
• No history of amputation surgery,
• Individuals using shoes suitable for insoles will be included in the study.

Exclusion Criteria

• • Using an assistive device (long-walking device, walker, canadiene, etc.),
• He has a history of amputation,
• He has a Charcot foot deformity,
• The one with the open wound,
• Physical disability that may restrict joint movement,
• Individuals using shoes that are not suitable for insoles will not be included in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Postural Balance	the evaluation of balance and postural control will be carried out before and in the 3rd month of insoles use and the effects on individuals will be compared.	Postural balance assessment in the study will be performed with 'Becure Balance System (Becure Global GmbH)'. It is planned to perform balance assessment of individuals on the device with eyes open-closed, single foot-double foot. After the participant is positioned on the balance board, balance evaluations will be made in different situations such as eyes open-closed, single foot-double foot. Changes in the centre of gravity on the x and y axes with the eyes open and closed, and changes in postural oscillation will be examined with the results of the distance of movement expressing the changes in the centre of gravity. The postural balance assessment conducted in the study provides all the parameters mentioned above in centimeters. These values represent postural sway.

Secondary Outcome Measures

Name	Time	Method
The Physiological Cost Index (PCI)	Evaluation will be made before and in the 3rd month of insoles use.	A simple and practical method for assessing walking efficiency and energy expenditure. These 3 measurements are obtained during the walking test; PCI = (Working HR - Resting HR) / Walking speed. The physiological expenditure index value reflects increased heart rate. In our project; PCI will be assessed with the 6 Minute Walk Test (6MWT).; (Heart rate and oxygen saturation (SpO2) will be recorded by pulse oximetry)

Trial Locations

Locations (1)

Istanbul Medipol University; 🇹🇷 İ̇stanbul, Turkey