Determining The effect of Propolis and Honey Lotion on Healing of Diabetic Foot Ulcers
Design
The clinical trial included a control and intervention group selected as a quadruple randomized block with a sample size of 60
Settings and conduct
The present clinical trial study will be performed on diabetic foot ulcer patients referred to the Tehran University Jihad Wound Center with the aim of determining the effect of propolis and honey lotion on healing of diabetic foot ulcer. This study was performed on patients with diabetic foot ulcer and Wagner 1 and 2 neuropathy. The face was chronically treated using digital caliper and BIM software to measure the extent and depth of the wound and after debridement and washing in both test and control groups, in the test group containing propolis and honey in the dressing group. The wound will be placed within one to four weeks depending on the size and size of the wound
Participants/Inclusion and exclusion criteria
Inclusion criteria: A1C Hemoglobin Level Should Not Exceed 8.
Insensitivity to Propolis and Honey.
Type 1 and Type 2 Diabetes.
Neuropathic Wounds of Diabetic Foot Wagner I and II
Be over 18 Years of Age.
4 Weeks Or More Has Elapsed Since The Injury.
Exclusion criteria:
Osteomyelitis
Active infection
Drug addiction
Intervention groups
The Wound In Both Groups Is Completely Defrozen Prior To Dressing With no Infections. The Control Group After Regular Debridement And wound Washing with Water, Became Regular Dressing. In the Test Group, The Lotion Containing Propolis and Honey will be Dressed on the wound. Propolis and Honey are Sterilized from Tehran University of Medical Sciences Jihad to Effectively Release Prophylactic Materials. That are Solubilized In Accordance with The Institute's Guidelines and Articles on the Proportion of Ethyl Alcohol. in honey.
Main outcome variables
Wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200113046120N1
Registration date:2020-03-02, 1398/12/12
Registration timing:retrospective
Last update:2020-03-02, 1398/12/12
Update count:0
Registration date
2020-03-02, 1398/12/12
Registrant information
Name
Elham Rasoulian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5544 6980
Email address
elham.rasoulian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
2019-09-11, 1398/06/20
Actual recruitment end date
2020-01-30, 1398/11/10
Trial completion date
2020-01-30, 1398/11/10
Scientific title
The Effect of Honey and Propolis Lotion on Healing of the Diabetic Foot Ulcers
Public title
The Effect of Honey and Propolis Lotion on Healing of the Diabetic Foot Ulcers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 1 and type 2 diabetes.
The presence of clear neuropathy in the lower limbs
Be over 18 years of age
It Takes Four Weeks Or More For The Wound To Develop
A1C hemoglobin Level Should Not Exceed 8.
No SensitivityTo Propolis and Honey
Patients with Wagner I and II Diabetic Foot Neuropathic Ulcer (Without Osteomyelitis Or Gangrene) in Areas of Pressure (Plantar Foot Surface
Exclusion criteria:
Osteomyelitis or the presence of congeners in the lower extremities
Drug addiction
Active wound infection
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The volume of the blocks was four, giving each block a number
Samples were randomly divided into four groups B, B, A, and A
Randomly assigned.
The volume of the block is quadruple and each block is assigned a number.
AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5
BAAB (6),
The numbers are randomly selected from 1 to 6 and the treatment allocation list is specified as such.
A-A-B-B-B-A-A-A-B-A-B-B-A-B-A.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No. 17, Enslave Street, South Palestine Street, Nazari Street
City
Tehran
Province
Tehran
Postal code
8915813127
Approval date
2019-04-15, 1398/01/26
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.031
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
Diabetic Foot Ulcerf
Timepoint
Evaluation of lotion containing propolis and honey in wound dressing according to the extent and size of the wound for one to four weeks
Method of measurement
Diabetic foot ulcer healing using digital caliper and BIM software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with Diabetic Foot Ulcers of Wagner 1 and 2 Neuropathies are Chronic. Propolis and Honey Lotion in This Study, packs in 25 cc Sterile Volume and Prepared From the BiotrapimericAcademicJihad Wound The wound heals within One to Four weeks, Depending on The Extent and Size of the Wound.
Category
Treatment - Other
2
Description
Control group: Diabetic foot ulcers are treated with Wegner 1 and 2 with simple dressing and received standard treatment.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University Jihad Wound Center
Full name of responsible person
Elham Rasoulian
Street address
No. 17, Enlargement Street, South Palestine Street, Nazari Street.,Tehran Town
City
Tehran
Province
Tehran
Postal code
8915813127
Phone
+98 21 6698 9110
Fax
Email
Elham.rasoulian@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarqi
Street address
e.g. No 2 , Arabi Ave., Velenjak., Tehran Town
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham.rasoulian
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Rajaie Heart Hospital, Valiasr Av
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.i
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham.rasoulian
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr Ave., Nayayehesh Highway., Tehran Town
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8877 0065
Email
info@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham rasoulian
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr Ave., Nayayeh Highway
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8877 0065
Email
Elham.rasoulian@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
Evaluation of propolis and honey lotion on diabetic foot ulcer
When the data will become available and for how long
6 month
To whom data/document is available
Comparison of mean changes of foot ulcer area in diabetic foot ulcer patients
Under which criteria data/document could be used
Wagner Diabetic Foot Wound Area 1 and 2
From where data/document is obtainable
University of Tehran of Jahad Ulcer
What processes are involved for a request to access data/document