Clinical trial NCT06846476: The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters
Official title: The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer (DFU)
Orthoses
Postural Balance
Plantar Pressure Distrubution
Keywords: Diabetic Foot
Insole
Postural Balance
Plantar Pressure
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There will be only one group in our study. This group will be evaluated before and in the 3rd month of insoles use.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postural Balance
timeFrame: 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.
Secondary outcomes:
measure: The Physiological Cost Index (PCI)
timeFrame: Evaluation will be made before and in the 3rd month of insoles use.
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: YAGMUR UYSAL
role: PRINCIPAL_INVESTIGATOR
References: