NCT06846476

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Insole	The production process of the insoles will be produced by Computer Aided Design and Computer Aided Manufacturing (CAD-CAM) method by making plantar pressure analysis and physical evaluation of the individual. The insoles will be designed to reduce the load in areas where the pressure is high with off loading technique. The design of the insoles to be produced individually will be made by the researcher (expert orthotist). The materials to be used in the production of insoles will be determined according to the needs of the participant and materials suitable for diabetic individuals will be preferred. In this context; mostly Ethyl Vinyl Acetate (EVA) and materials with cellular air permeability on the upper surface will be used.
OTHER	Demographic Information and Anamnesis Form	Demographic information and anamnesis form; demographic information of the participant, disease history, physical condition of the foot, skin condition, medications used, allergic status, surgical history, presence of edema, discolouration and temperature increase.
OTHER	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 both static and dynamic conditions. Foot plantar pressure analysis and postural balance will be performed using the EsCoSCAN® static and dynamic 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. This evaluation will be performed before and 3 months after the use of insoles.
OTHER	Postural balance	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. This evaluation will be performed before and 3 months after the use of insoles.
OTHER	The Foot Functional Index (FFI)	The Foot Functional Index (FFI) consists of pain, disability and activity limitation and contains a total of 23 items. Pain and disability titles consist of 9 questions each. The pain item measures the severity of foot pain in different situations. The 9 items in the inability heading assess the severity of the difficulty in performing functional activities due to the person's foot problems. The activity limitation heading consists of 5 items and measures the activity limitations of the person due to foot problems. AFI is a self-completed scale. Individuals answer the questions with a Visual Analogue Scale (VAS), taking into account their foot condition one week ago. A high score indicates more pain, inability and activity limitation. This evaluation will be performed before and 3 months after the use of insoles.
OTHER	Sensory Evaluation	Diabetic foot ulcer (DFU), which is one of the microvascular complications of diabetes, frequently occurs in association with loss of protective sensation due to peripheral neuropathy, ischaemia due to peripheral arterial insufficiency, poor foot care and infection. Loss of pressure sensation caused by peripheral nerve damage will be evaluated with 'Semmes Weinstein' monoflaments. The 5.07 nylon monoflament used in the test was produced to bend when 10 g force was applied. This pressure is applied to specific points on the plantar and dorsal aspect of the foot. This evaluation will be performed before and 3 months after the use of insoles.
OTHER	Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0)	It is a standardised and widely used questionnaire developed to examine the satisfaction of individuals using orthotics with the device they use. In 2020, a Turkish validity and reliability study was conducted. QUEST 2.0 consists of 12 items. Of these, 8 items question the assistive device and 4 items question service satisfaction. Scale scoring is calculated with a 5-point Likert scale (1=Not satisfied at all, 5=Very satisfied). This evaluation will be performed after the use of insoles.
OTHER	6 Minute Walk Test (6MWT)	Participants will walk for 6 minutes at a speed of their choice in a flat and suitable area of 30 metres. The distance walked in 6 minutes will be recorded in metres.
OTHER	Pulse Oximeter Heart Rate and Oxygen Saturation	Heart rate and oxygen saturation (SpO2) will be recorded by pulse oximetry before and after the 6MWT. The pulse oximeter is a non-invasive device that attaches to a person's fingertip.

Timeline

• Start date: 2024-12-24
• Primary completion: 2025-05-08
• Completion: 2025-08-15
• First posted: 2025-02-26
• Last updated: 2025-09-19

Locations

1 site across 1 country: Turkey (Türkiye)