Diabetic Foot Ulcer (DFU)NCT06846476
The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters
A study testing Insole, Demographic Information and Anamnesis Form and Pedobarographic analysis in people with Diabetic Foot Ulcer (DFU) and Orthoses, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Orthoses, Postural Balance
- What is being tested?
- Insole, Demographic Information and Anamnesis Form and Pedobarographic analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 35 and 70,
- 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Istanbul, 34794
About this study
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.
Read the 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.
- Being tested
- Insole, Demographic Information and Anamnesis Form, Pedobarographic analysis, Postural balance, The Foot Functional Index (FFI)
- Keywords
- Diabetic Foot, Insole, Postural Balance, Plantar Pressure
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsoleOther
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.
Demographic Information and Anamnesis FormOther
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.
Pedobarographic analysisOther
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.
Postural balanceOther
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.
The Foot Functional Index (FFI)Other
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.
Sensory EvaluationOther
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.
Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0)Other
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.
6 Minute Walk Test (6MWT)Other
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.
Pulse Oximeter Heart Rate and Oxygen SaturationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Using diabetic insole and will participate in all assessment methods. Receives: Other: Insole; Other: Demographic Information and Anamnesis Form; Other: Pedobarographic analysis; Other: Postural balance; Other: The Foot Functional Index (FFI); Other: Sensory Evaluation; Other: Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0); Other: 6 Minute Walk Test (6MWT); Other: Pulse Oximeter Heart Rate and Oxygen Saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Balance
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.
Measured: 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 (1)
The Physiological Cost Index (PCI)
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)
Measured: Evaluation will be made before and in the 3rd month of insoles use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start24 Dec 2024
- Primary completion8 May 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur UYSAL, Medipol University
- Investigators
- YAGMUR UYSAL, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846476
- Sponsor's protocol ID
- MedipolU-OPZ-YU-01
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not sure
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters
- ClinicalTrials.gov ID
- NCT06846476
- Acronym / sponsor ID
- MedipolU-OPZ-YU-01
- Keywords
- Diabetic Foot, Insole, Postural Balance, Plantar Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: Insole, Other: Demographic Information and Anamnesis Form, Other: Pedobarographic analysis, Other: Postural balance, Other: The Foot Functional Index (FFI), Other: Sensory Evaluation, Other: Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0), Other: 6 Minute Walk Test (6MWT), Other: Pulse Oximeter Heart Rate and Oxygen SaturationUsing diabetic insole and will participate in all assessment methods. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between the ages of 35 and 70,
- 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.
Key exclusion criteria (6 listed)
- - 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsoleThe 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 | All participants |
| Demographic Information and Anamnesis FormDemographic 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 | All participants |
| Pedobarographic analysisPedobarographic 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 | All participants |
| Postural balancePostural 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 | All participants |
| 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 | All participants |
| Sensory EvaluationDiabetic 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 | All participants |
| 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 | All participants |
| 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 | All participants |
| Pulse Oximeter Heart Rate and Oxygen SaturationHeart 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. | Other | All participants |
Primary outcome
Postural Balance
Time frame: 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.
1 secondary outcome
The Physiological Cost Index (PCI)
Time frame: Evaluation will be made before and in the 3rd month of insoles use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Not sure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YAGMUR UYSAL principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insole, Demographic Information and Anamnesis Form and Pedobarographic analysis in people with Diabetic Foot Ulcer (DFU) and Orthoses, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Balance (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.