Comparison of the effect of two types of offloading insoles on the balance of patients with diabetic foot ulcers

Comparision between puzzle insole and conventional four-layer insole with offloading rocker sole shoe on dynamic balance and spatio-temporal parameters of gait in patients with diabetic foot ulcers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240405061417N1

Enrollment

Registered

2024-08-06

Start date

2024-06-21

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic polyneuropathy. Diabetic polyneuropathy

Interventions

Intervention 1: Intervention group: offloading shoes with a 20-degree rocker sole with a conventional four-layer insole. Rocker insole shoe is a type of footwear modification where the sole of the sh

Eligibility

Sex/Gender

All

Age

40 Years to 60 Years

Inclusion criteria

Inclusion criteria: Diabetic patients with foot ulcers only due to neuropathy The ulcer of the forefoot The maximum size of the ulcer is 2x2 cmm The age of patients should be between 40 and 60 years Diabetic foot ulcer is shallow No amputation of fingers Absence of disease due to imbalance such as Parkinson's, MS, vestibular disorders or similar cases Not taking drugs that affect balance Have no history of using the researched off-loading shoes

Exclusion criteria

Exclusion criteria: The ulcer is on the foot or leg or in the hindfoot The vascular ulcers or neurovascular ulcers The ulcer has involved the bone

Design outcomes

Primary

Measure	Time frame
Step legnth: The length measured parallel to the forward line of the body from the heel contact of one foot to the heel contact of the other foot. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software.;Step time: The time interval between the heel contact of one foot with the ground and the heel contact of the opposite foot with the ground. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software.;Stance time percentage :This phase starts when the foot is in contact with the ground and with the complete separation of the same foot from the groundIt ends. The stance phase constitutes approximately 60% of the walking phase. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software.;The time percentage of the midstance phase: in observation; This phase of walking starts with the separation of the toes of the opposite foot from the ground and continues until the heel of the progressive foot is in contact with the ground and accounts for 29 to 37% of walking. Timepoint: Along with	—

Measure

Time frame

Step legnth: The length measured parallel to the forward line of the body from the heel contact of one foot to the heel contact of the other foot. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software.;Step time: The time interval between the heel contact of one foot with the ground and the heel contact of the opposite foot with the ground. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software.;Stance time percentage :This phase starts when the foot is in contact with the ground and with the complete separation of the same foot from the groundIt ends. The stance phase constitutes approximately 60% of the walking phase. Timepoint: Along with the patient's own shoes. After wearing shoes with a 20 degree rocker sole with a conventional four-layer insole. After wearing shoes with a 20 degree rocker sole with a puzzle insole. Method of measurement: In this study will be measured by Treadmill device for systematic analysis of walking and running, and will be calculated and recorded with T-FDM zebris software.;The time percentage of the midstance phase: in observation; This phase of walking starts with the separation of the toes of the opposite foot from the ground and continues until the heel of the progressive foot is in contact with the ground and accounts for 29 to 37% of walking. Timepoint: Along with

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAkram Tadi Beni

Iran University of Medical Sciences

tadibeni.a@iums.ac.ir+98 21 2640 5626

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026