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IRCT20201212049687N4 IRCT 2023-12-14 Esfahan University of Medical Sciences Investigating the critical threshold of plantar pressure in people with diabetes with healed wounds Determining the critical threshold of plantar pressure in diabetic people with healed wounds in Tehran and determining the elastographic characteristics of the plantar tissue of these patients following the use of customized insoles 2023-12-16 anticipated 150 Complete https://irct.ir/trial/74249 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research. N/A diabetes. Intervention group: After determining the sole pressure threshold, in the next step, the firmness of the skin of the soles is determined with the elastography device, and a number of people are selected to make insoles and shoes, and after using the insoles and shoes, elastography will be performed again.. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying people, also part of the data related to the main outcome can be shared. When: The access period starts one year after the results are published To whom: The data will only be available to researchers working in academic and scientific institutions Conditions: Specialists in the field of orthotics and prosthetics and diabetes can receive the data after requesting and diagnosing the correct use Where to obtain: Applicants should only refer to the email address How to obtain: After sending the request to my email and reviewing the request, a response will be sent within 15 days Comments:

public alireza taheri

school rehabilitation , hezajirib St., Isfahan

Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5053 taheri@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific alireza taheri

school rehabilitation , hezajirib St., Isfahan

Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5053 taheri@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) neuropathic diabetic people of of tehran city of both genders aged 30 to 80 years old Ability to read, write and understand Farsi People with a history of wound in forefoot that has been fully healed for at least 90 days Ability to walk independently without needing Assistance the ability to walk and stand without the use of assistive devices 30 years 80 years Both The presence of any type of amputation in the lower limb or the presence of any wound on the sole of the foot Movement limitation of lower limb joints (ankle, knee and hip) which cause instability in standing and walking Charcot arthropathy condition. Peripheral vascular diseases A history of surgery in the back or lower limbs during the last six months or accompanying diseases that cause movement restriction and instability while walking Rehabilitation Intervention group: After determining the sole pressure threshold, in the next step, the firmness of the skin of the soles is determined with the elastography device, and a number of people are selected to make insoles and shoes, and after using the insoles and shoes, elastography will be performed again. Prediction of points with high risk of wound. Timepoint: Measurement of blood pressure threshold at the beginning of the study (before the start of the intervention) and one month after the intervention. Method of measurement: plantar pressure measurement device (pedar) and sole skin firmness device (elastography). Esfahan University of Medical Sciences Approved 2023-11-29 Ethics committee of Isfahan University of Medical Sciences school rehabilitation , hezajirib St., Isfahan Town Isfahan Isfehan Iran (Islamic Republic of)