The Effectiveness of Biomechanically optimized Custom Footwear on the functional mobility and gait of Diabetic people with Charcot : A Mixed-Methods Approach
Determining the effect of customized shoes with biomechanical optimization on movement performance and walking of people with chronic diabetic Charcot.
Design
After physical evaluation by questionnaire about neuropathy condition and vibration perception test and tactile evaluation and evaluation of sensory symptoms as well as evaluation of foot deformities and the presence of calluses as well as passive range of motion in the wrist and thumb a molded and modified shoe and insole according to The condition of each person's foot is prepared and after 2 and 8 weeks of using shoes, movement performance and walking are checked.
Settings and conduct
This study is conducted in the diabetes centers of Isfahan University of Medical Sciences in two phases, qualitative and quantitative, using a gait analysis device and making shoes and insoles.
Participants/Inclusion and exclusion criteria
1. Diabetic Charcot neuroarthropathy 2. Having chronic diabetic Charcot 3. The third stage of Eichenholtz's classification
4. foot amputation 5. Any wound and active infection in the foot and ankle area
Intervention groups
Charcot foot patients
Main outcome variables
1. Pain reduction
2. Improvement of walking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201212049687N5
Registration date:2024-07-08, 1403/04/18
Registration timing:registered_while_recruiting
Last update:2024-07-08, 1403/04/18
Update count:0
Registration date
2024-07-08, 1403/04/18
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
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Biomechanically optimized Custom Footwear on the functional mobility and gait of Diabetic people with Charcot : A Mixed-Methods Approach
Public title
The optimized Custom Footwear on the functional mobility and gait of Diabetic people with Charcot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Diabetic Charcot neuroarthropathy 2. Having chronic diabetic Charcot 3. The third stage of Eichenholtz's classification
Exclusion criteria:
1. foot amputation 2. Any wound and active infection in the foot and ankle area
Age
From 30 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.MUI.REC.1403.008
Health conditions studied
1
Description of health condition studied
charcot
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain - motor function - walking
Timepoint
Measurement of pain and movement function at the beginning of the study (before the intervention) and 2, 8 weeks after starting to use shoes and insoles.
Method of measurement
Pain questionnaire (VAS) - gait analysis device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Medical shoes with long claws, enough width in the head of the metatarsals to match all types of deformities, wide heel and adjustable shoe upper by velcro.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 7925 0503
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
Dr. Gholamreza Asgari
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 7925 0503
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
alirezataheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 31 7925053
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
alirezataheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 31 7925053
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
alirezataheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 0792 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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The entire data can potentially be shared after de-identifying people or, for example, only part of the data, such as information related to the main outcome or the like, can be shared.
When the data will become available and for how long
The access period starts 12 months after the results are published
To whom data/document is available
Only researchers working in academic and scientific institutions
Under which criteria data/document could be used
General analyzes on the data will be provided via email
From where data/document is obtainable
by Email
What processes are involved for a request to access data/document
First, the requested email is checked and the necessary information is transferred