The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters
Key facts
- Who runs it
- Medipol University
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 25 people enrolled
- Started
- 24 Dec 2024
- Ended
- 15 Aug 2025
- Type of study
- Interventional
- Treatments tested
- Insole
- Demographic Information and Anamnesis Form
- Pedobarographic analysis
- Postural balance
- The Foot Functional Index (FFI)
- Sensory Evaluation
- Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0)
- 6 Minute Walk Test (6MWT)
- Pulse Oximeter Heart Rate and Oxygen Saturation
- Record updated
- 29 June 2026
Who can take part
- Age
- 40 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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 take part
- He has a history of amputation,
- - Using an assistive device (long-walking device, walker, canadiene, etc.),
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- All participantsTreatment being tested
Using diabetic insole and will participate in all assessment methods.
Treatment: Insole, Demographic Information and Anamnesis Form, Pedobarographic analysis, Postural balance, The Foot Functional Index (FFI), Sensory Evaluation, Orthotic Satisfaction Questionnaire- Q-YTKMD (QUEST 2.0), 6 Minute Walk Test (6MWT), and Pulse Oximeter Heart Rate and Oxygen Saturation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 29 June 2026