Protocol summary

Study aim
Determining the effect of education through "Zakhm yar" application on foot care in older adults with diabetic foot ulcer
Design
Clinical trial with control group, with parallel groups, unblinded, randomized, on 114 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
By referring to Endocrine & Metabolism Research Institute, two intervention and control groups are randomly selected from among the referring patients who meet the conditions for entering the study, and blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being between 60 and 80 years old, Definitive diagnosis of diabetes, Access and ability to use a smart phone Exclusion criteria: The presence of severe disease complications such as wound infection, osteomyelitis, Charcot's foot, Participation in similar treatment plans in the last three months.
Intervention groups
Intervention group: For the Intervention group, a mobile educational application will be designed to be used on smart phones with Android and iOS operating systems to teach the components of diabetic foot ulcer care in a multimedia way. The multimedia training program designed by the researcher will include educational guidelines on how to care for diabetic foot ulcers to family caregivers of patients. This educational program will be presented in the form of "Zakhm Yar" application. Control group: will only receive the usual training and care.
Main outcome variables
foot care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240612062102N1
Registration date: 2024-08-17, 1403/05/27
Registration timing: prospective

Last update: 2024-08-17, 1403/05/27
Update count: 0
Registration date
2024-08-17, 1403/05/27
Registrant information
Name
Amirhosein Bigdelou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
amirhosseinbigdelou1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-10, 1403/06/20
Expected recruitment end date
2024-12-10, 1403/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education through "Zakhm yar" application on foot care in older adults with diabetic foot ulcer
Public title
The effect of education through "Zakhm yar" application on foot care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 60 and 80 years old Definitive diagnosis of diabetes Access and ability to use a smart phone
Exclusion criteria:
The presence of severe disease complications such as wound infection, osteomyelitis, Charcot's foot Participation in similar treatment plans in the last three months
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method will initially be convenience; The samples will then be placed in quadruple blocks by block random sampling. The blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment, we will have 4 blocks (including 2 participants in the intervention group and 3 participants in the control group). Random allocation software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 604, 6th Floor, Central Building, Tehran University of Medical Sciences Intersection of Qods Street, Keshavarz Boulevard Office of the Ethics Committee for Biomedical Research, University of Tehran
City
Tehran
Province
Tehran
Postal code
1417994575
Approval date
2024-04-29, 1403/02/10
Ethics committee reference number
IR.TUMS.EMRI.REC.1403.010

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E08.621
ICD-10 code description
Diabetes mellitus due to underlying condition with foot ulcer

Primary outcomes

1

Description
foot care
Timepoint
Before and six weeks after the intervention
Method of measurement
Diabetic foot care questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the Intervention group, a mobile educational application will be designed to be used on smart phones with Android and iOS operating systems to teach the components of diabetic foot ulcer care in a multimedia way. The multimedia training program designed by the researcher will include educational guidelines on how to care for diabetic foot ulcers to family caregivers of patients. This educational program will be presented in the form of "Zakhm Yar" application.
Category
Rehabilitation

2

Description
Control group: They will receive only the usual training and care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine & Metabolism Research Institute
Full name of responsible person
Dr Afshin Ostovar
Street address
Next to Shariati Hospital, Jalal Al Ahmad Street,
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8822 0053
Email
emrc@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Hossein Ghanaati
Street address
Keshavarz Boulevard, Quds corner, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Tehran University of Medical Sciences
Full name of responsible person
Amir Hossein Beigdelou
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St. (East Nusrat), Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
amirhosseinbeig1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sarieh Poortaghi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St. (East Nusrat), Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
amirhosseinbeig1997@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hossein Beigdelou
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St. (East Nusrat), Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
amirhosseinbeig1997@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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