Determining and comparing wound characteristics and dimensions in the control group before and after the intervention during three months
Determining and comparing wound characteristics and dimensions in the intervention group before and after the intervention during three months
Comparison of wound characteristics and dimensions in the two groups of intervention and control before and after the intervention during the three
Design
Two-group randomized clinical trial
Two-way blind-randomized based random number table with 4 permutations on 94 patients
Settings and conduct
The study was performed at the Ozone Therapy Center of Baqiyatallah Hospital.
Patients who are being treated for foot ulcers with ozone bags are randomly divided into two groups
In the intervention group, a comprehensive care program is performed and in the other group, no intervention is performed
In both groups, on the first day and after each visit, images with equal distance (30 cm) were taken from the wound, the length and width of the wound were recorded using a measuring ruler. The image is taken in such a way that the measuring ruler in the image shows the size of the wound
The study will be followed up until the wound heals or finally until three months after the start of the study
Blinding will be performed for the physician and caregiver performing ozone therapy and for the findings analyzer
Participants/Inclusion and exclusion criteria
Age 18 to 65 years, with grade 3 diabetic Wegener foot without gangrene, prescribed Ozone bag method for ozone therapy
Intervention groups
Both groups receive ozone twice a week through a special bag for 20 minutes with regular wound washing and dressing changes every 12 hours.
In the intervention group, a comprehensive patient care program is implemented from the very beginning
Main outcome variables
Wound size
Wound depth
Wound characteristics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200830048555N1
Registration date:2021-05-02, 1400/02/12
Registration timing:retrospective
Last update:2021-05-02, 1400/02/12
Update count:0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Zahra Rooddehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
rooddehghan@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of comprehensive care program on the rate of wound healing in Diabetic Foot Patients treated with ozontherapy
Public title
Effect of comprehensive care program on the rate of wound healing in Diabetic Foot Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 65 years
With type one or two diabetes
Having grade 3 diabetic foot according to Wegener criteria
No pregnancy
Not having hyperthyroidism
Absence of gangrene in the whole ankle
No active osteomyelitis
Complete the consent form
Prescribe an ozone bag method for ozone therapy
There is a wound on one of the legs
Exclusion criteria:
Reluctance to continue research
Transformation and treatment model in a more complex way
The doctor decides to amputate
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria enter the study in an accessible manner,
The allocation method according to the table of random numbers with 4 permutations will be used. It will be determined that the intervention group with A and the control group with B and according to the patterns obtained from the table of random numbers, sampling will continue until the number of samples reaches the quorum in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Physician and clinical care provider
Physicians and clinicians do not know which patient group is participating in the comprehensive training program
Data Analyzer
The obtained data is provided to the statistical analyst through the code of groups one and two
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research School of Nursing and Midwifery and School of Rehabilitation
Street address
School of Nursing Midwifery,Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-10-18, 1399/07/27
Ethics committee reference number
IR.TUMS.FNM.REC.1399.113
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcers in ozone therapy
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Size of diabetic foot ulcers according to Wegener scale
Timepoint
The first day of the examination and re-visit each time
Method of measurement
Take a photo of the wound at a distance of 30 cm while there is a measuring ruler & Wound depth with sterile applicator
2
Description
characteristics of diabetic foot ulcers according to Wegener scale
Timepoint
The first day of the examination and re-visit each time
Method of measurement
Wound characteristic with checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, a comprehensive care plan for patients is started from the very beginning, and the necessary instructions are given to the patient individually, and a checklist is given in order for the patient to pay attention to the issues that need to be addressed.The patient should record information in it daily so that the level of comprehensive care plan can be checked. Twice a week, each patient will be contacted at a specific time agreed upon by the patient to answer the patient's questions and follow up on a comprehensive care plan
Category
Rehabilitation
2
Description
Control group: without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Ozone Therapy Center
Full name of responsible person
Dr. Morteza Izadi
Street address
No 349, Nosrat st.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6665 8333
Email
Zrooddehghan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Gheranmayeh
Street address
Nosrat st., Tohid sq., Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@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
Zahra Rooddehghan
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st.
City
Tehran
Province
Tehran
Postal code
141973317
Phone
0098216927171
Email
Zrooddehghan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Rooddehghan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st.
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6692 7171
Email
Zrooddehghan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Rooddehghan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Zrooddehghan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of participants' information
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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data will not be published
When the data will become available and for how long
After the publication of related articles
To whom data/document is available
Judges who intend to check the accuracy of the study
Under which criteria data/document could be used
Judges who intend to check the correctness of the study
From where data/document is obtainable
correspondent author
Dr.Zahra Rooddehghan
Nosrat st. Tohid sq. Tehran I.IRAN 141973317
00989126945759
What processes are involved for a request to access data/document
Email the responsible author and explain the reason for requesting the data and receiving the request within two weeks