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NCT06846476 | NOT YET RECRUITING | Diabetic Foot Ulcer (DFU)


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

Medipol University

Information provided by (Responsible Party):

Rain Uysal

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.

Condition or disease

Diabetic Foot Ulcer (DFU)

Orthoses

Postural Balance

Plantar Pressure Distrubution

Intervention/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)

Pulse Oximeter Heart Rate and Oxygen Saturation

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Effect of Using Insoles Specially Designed for Diabetic Foot on Postural Balance and Gait Parameters
Actual Study Start Date : 2025-04-21
Estimated Primary Completion Date : 2025-08-21
Estimated Study Completion Date : 2025-11-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT06846476


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Locations


Not yet recruiting

Turkey,

Istanbul Medipol University

Istanbul, Turkey, 34794

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