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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

Protocol summary

Study aim
Determining the critical threshold of plantar pressure in people with diabetes with healed plantar ulcer in Tehran
Design
In the first phase, a group of 150 people was selected, and after determining the pressure threshold, in the second phase, 30 people were selected to make insoles, and in the third phase, after using the insoles, elastography was performed again.
Settings and conduct
This study is in 3 phases, in the first step, sampling with the available method and selecting 150 people and collecting information about plantar pressure using the Pedar device, in the second step, making medical insoles based on the offload of high pressure points, and in the last step, using the elastography technique, on 30 people before and after medical insole intervention.
Participants/Inclusion and exclusion criteria
Diabetic neuropathic patients of both sexes, aged between 30 and 80 years, with a history of ulcers in the toe area, which is at least 90 days from complete recovery and the ability to walk without assistance, and people with amputations in the lower limbs or ulcers in the soles of the feet and restrictions Mobility of lower limb joints and having Charcot arthropathy or peripheral vascular diseases and history of lower limb surgery are excluded from the study.
Intervention groups
Custom-made and offload at points where the pressure is high
Main outcome variables
Predicting points with high risk of ulcers, preventing recurrence of ulcers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201212049687N4
Registration date: 2023-12-14, 1402/09/23
Registration timing: prospective

Last update: 2023-12-14, 1402/09/23
Update count: 0
Registration date
2023-12-14, 1402/09/23
Registrant information
Name
َAlireza Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5053
Email address
taheri@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-16, 1402/09/25
Expected recruitment end date
2025-03-15, 1403/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the critical threshold of plantar pressure in people with diabetes with healed wounds
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
school rehabilitation , hezajirib St., Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
8074673461
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.MUI.REC.1402.032

Health conditions studied

1

Description of health condition studied
diabetes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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)

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kausar Diabetes Center
Full name of responsible person
Alireza Taheri
Street address
School rehabilitation, Hezajirib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Taheri
Street address
School rehabilitation, Hezajirib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
60
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
alireza taheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
school rehabilitation , hezajirib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
alireza taheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis and prosthesis
Street address
school rehabilitation , hezajirib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
alireza taheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthosis and prosthesis
Street address
school rehabilitation , hezajirib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared after de-identifying people, also part of the data related to the main outcome can be shared.
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
The data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Specialists in the field of orthotics and prosthetics and diabetes can receive the data after requesting and diagnosing the correct use
From where data/document is obtainable
Applicants should only refer to the email address
What processes are involved for a request to access data/document
After sending the request to my email and reviewing the request, a response will be sent within 15 days
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