The effect of Aloe vera jel on healing of first degree diabetic foot ulcer in patient who admitted in wound clinic Shahid mohammadi Hospital in bandar abbas
=The effect of Aloevera jel on healing of first degree diabetic foot ulcer in patient who admitted in wound clinic Shahid mohammadi Hospital
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Intervention is at Shahid Mohammadi Hospital in Bandar Abbas. The wounds are washed daily with 0.9% normal saline. In the experimental group, after washing the wound with normal saline, aloe vera gel (a thin layer that covers the entire wound) is used. According to the hospital routine, the bandages are changed daily and examined.
Wound Assessment Tool is a Bates-genus instrument that includes 15 items and examines the size, type and depth
Blindness is double blind
Participants/Inclusion and exclusion criteria
Study inclusion criteria:
1- Diabetic foot ulcer with a size of less than 10 cm
2-Patients without a history of cancer, AIDS and severe skin allergies and skin problems
3- Do not smoke or drink alcohol
4- Do not use other materials for dressing
5- Patient age between 30 to 70
6- The interval between wounding and entering the study is less than one day
7- able to answer
8- Willingness to participate in the study
Exclusion criteria:
1- History of allergy to aloe vera
Intervention groups
The wounds are whashed daily with 0.9% normal saline. In the intervention group, after washing the wounds with normal saline, aloe vera gel (a thin layer that covers the entire wound) is used. According to the hospital routine, the bandages are changed daily and examined.
Main outcome variables
Accelerate the healing of diabetic foot ulcers
General information
Reason for update
Acronym
aloe vera
IRCT registration information
IRCT registration number:IRCT20141130020151N2
Registration date:2021-08-18, 1400/05/27
Registration timing:registered_while_recruiting
Last update:2021-08-18, 1400/05/27
Update count:0
Registration date
2021-08-18, 1400/05/27
Registrant information
Name
Parichehr Sabaghzadeh Irani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 000000
Email address
parichehr_sabaghzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aloe vera jel on healing of first degree diabetic foot ulcer in patient who admitted in wound clinic Shahid mohammadi Hospital in bandar abbas
Public title
The effect of Aloe vera jel on healing of first degree diabetic foot ulcer in patient who admitted in wound clinic Shahid mohammadi Hospital in bandar abbas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot ulcers less than 10 cm in size
Not more than one day has passed from the time of wounding to the time of hospitalization
It does not have cancer, AIDS, severe skin allergies and skin problems
Do not use cigarettes
Be willing to participate in research
The wound is not bandaged with any substance
Do not use any substance other than 0.9% normal saline on the wound
he patient should be between 30 and 70 years old
Do not use alcohol
be able to answer questions as well
Exclusion criteria:
History of allergy to aloe vera
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
First, the samples are entered into the study based on the inclusion criteria. Then the selection of the control group and the intervention is done by simple random method. Randomization tool is the use of opaque and similar cards. In this method, the word intervention is written on one card and the control card on the other. The cards are opaque and are quite similar in weight and appearance. The cards are then placed in front of the patient and the patient selects a card. This process continues until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were unaware of the type of dressing.
The filler questionnaire did not know the type of dressing
Placebo
Not used
Assignment
Parallel
Other design features
nothing
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-01-04, 1399/10/15
Ethics committee reference number
IR.KMU.REC.1399.567
Health conditions studied
1
Description of health condition studied
Patients with first degree diabetic foot ulcer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the wound tool score Bates-Jensen
Timepoint
Once every 7 days for 21 days
Method of measurement
the wound tool score Bates-Jensen
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In the intervention group, first the wounds are washed daily with 0.9% normal saline, then a thin layer of aloe vera gel is used to cover the whole wound, then the wound is closed with a sterile gauze bandage. Dressings are changed daily for 21 days (three weeks) and checked each time they are changed. At the end of each dressing (once a week), a wound examination tool is recorded. Aloe vera gel is produced by Barij Essential Oil Company.
Category
Treatment - Drugs
2
Description
Control group:In the control group, wounds after dressing with normal saline 0.9% are bandaged with sterile gauze and bandage. Dressings are changed daily for 21 days (three weeks) and checked each time they are changed. At the end of each dressing (once a week), a wound examination tool is recorded.roup:
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohamadi hospital
Full name of responsible person
MR yaser khanche mehr
Street address
Hormozgan Province, Bandar Abbas, Kuy e Farhangiyan, Payambar aazam medical educational complex
City
bandar abbas
Province
Hormozgan
Postal code
7614763154
Phone
+98 76 3334 7000
Fax
Email
shmh@hums.ac.ir
Web page address
http://shmh.hums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
dr. ababs pardakhti
Street address
Ebn-e-Sina St.,Jahad Blvd., Kernan,Iran
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
1
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
Kerman University of Medical Sciences
Full name of responsible person
parichehr sabaghzadeh irani
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
parichehr_sabaghzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
parichehr sabaghzadeh irani
Position
phd student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
parichehr_sabaghzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
parichehr sabaghzadeh irani
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
parichehr_sabaghzadeh@yahoo.com
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
All data is published in such a way that the names of the participants are not disclosed
When the data will become available and for how long
After printing the results and at the time of submission to the judges of the journals
To whom data/document is available
All members of the research team, all reviewers of journals whose work results are sent for publication, and all researchers
Under which criteria data/document could be used
In case of citing researchers, doing work is not prohibited
From where data/document is obtainable
parichehr sabaghzadeh irani
What processes are involved for a request to access data/document