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

Last updated: September 15, 2025
Sponsor: Medipol University
Overall Status: Completed

Phase

N/A

Condition

Ulcers

Diabetes And Hypertension

Treatment

Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0)

The Foot Functional Index (FFI)

Pulse Oximeter Heart Rate and Oxygen Saturation

Clinical Study ID

NCT06846476
MedipolU-OPZ-YU-01
  • Ages 40-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 inthe study.

Study Design

Total Participants: 25
Treatment Group(s): 9
Primary Treatment: Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0)
Phase:
Study Start date:
December 24, 2024
Estimated Completion Date:
August 15, 2025

Study 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.

Connect with a study center

  • Istanbul Medipol University

    İ̇stanbul, 34794
    Turkey

    Site Not Available

  • Istanbul Medipol University

    Istanbul 745044, Istanbul 745042 34794
    Turkey (Türkiye)

    Site Not Available

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