CompletedNot Applicable

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

Turkey (Türkiye)25 participantsStarted 2024-12-24

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT06846476

SponsorMedipol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-08

View on ClinicalTrials.gov More Diabetic Foot Ulcer (DFU) trials