Objectives:comparing the effect of olive oil and honey on the healing of diabetic foot ulcer in patients with type 2 diabetesis. Design: This Study will be a Clinical Trial. Sixty (60) patients with type 2 diabetes selected by a purposive sampling and randomly will be divide into two experimental and one control groups. Major Inclusion and Exclusion criteria:at least 9 months history of type 2 diabetes; having a diabetic wound grade 1 and 2; having 20-60 years old
Exclusion criteria will be include history of sensitivity to the Olive and Honey;suffering from kidney and liver desease
Intervention: "Intervention group1: received topical olive oil in addition to routine
cares".
routine cares will include the ulcers was irrigated and cleaned sterile
normal saline solution every day and after making dry was dressed with sterile gauze.
"Intervention group2: received topical honey in addition to routine
cares".
"Control group: patients did not receive any special treatment by the investigator and the samples of control group had received routine care".
main outcome measures :diabetic foot ulcer will be measured before the intervention and every weeks up to four weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082928017N3
Registration date:2016-09-05, 1395/06/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-05, 1395/06/15
Registrant information
Name
Mohammad Behnammoghadam
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 5041
Email address
m.behnammoghadam@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasooj University of Medical Sciences
Expected recruitment start date
2016-08-18, 1395/05/28
Expected recruitment end date
2018-02-06, 1396/11/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of olive oil and honey on the healing of diabetic foot ulcer in patients with type 2 diabetes
Public title
Comparing the effect of olive oil and honey on the healing of diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:at least 9 months history of type 2 diabetes; having a diabetic wound grade 1 and 2; having 20-60 years old
exclusion criteria: history of sensitivity to the Olive and Honey; lack of any kidney and liver disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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 Yasuj University of Medical Sciences
Street address
Shahid Motahari Blvd, Yasuj
City
Yasuj
Postal code
Approval date
2016-08-14, 1395/05/24
Ethics committee reference number
IR.YUMS.REC.1395.80
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E10.7
ICD-10 code description
Insulin-dependent diabetes mellitus with multiple complications
Primary outcomes
1
Description
Healing of diabetic foot ulcers
Timepoint
Weekly
Method of measurement
Based on diabetic foot ulcers check list
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group1: received topical olive oil in addition to routine
cares".
Category
Treatment - Other
2
Description
"Intervention group2: received topical honey in addition to routine
cares".
Category
Treatment - Other
3
Description
"Control group: patients did not receive any special treatment by the investigator and the samples of control group had received routine care
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh Medical Clinic of Yasuj
Full name of responsible person
Mohammad Behnammoghadam, Master of Critical Care Nursing
Street address
Montazeri Street, Yasuj
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Dr. Mousavi
Street address
Shahid Motahari Blvd, Yasuj
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Yasuj University of Medical Sciences