The purpose of this clinical trial study is to assess the effect of topical olive oil on the healing of foot ulcer in patients with type 2 diabetes. After obtaining informed consent from patients, 34 type 2 diabetic patients with diabetic foot ulcers of grade 1 and 2 in the feet, toes, heels and feet will select and randomly assign to groups of intervention and control. Classification of wound degree will perform using the Wegener criteria. Initially, in both groups wound wash based on routine procedures of hospital. Then wound in the intervention group will dress with olive oil and in the control group just simple gaze will use without any topical drug. This procedure will do once a day for 1 month in both groups. In the end of each week, the wound would be assessed and scored with diabetic ulcer healing check list by a specialist who is unaware of group’s assignment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014083014251N2
Registration date:2014-09-05, 1393/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-05, 1393/06/14
Registrant information
Name
MORTEZA NASIRI
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 2622 5292
Email address
nasiri.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-07-05, 1393/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical olive oil on the healing of foot ulcer in patients with type 2 diabetes in Ahvaz diabetes cinic in 2013
Public title
The effect of topical olive oil on the healing of foot ulcer in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having a diabetic wound grade 1 and 2 based on Wegener's classification ; having foot ulcers in the extremities (fingers, soles, heels, or foot) that have created at least 4 weeks before ; having a body mass index 18 to 35 ; lack of any history of addiction and cigarette and alcohol abuse ; lack of using any drug that may delays wound healing such as: corticosteroids, immunosuppressive and cytotoxic agents ; lack of any chronic diseases other than diabetes that may affect the healing of wounds such as cancers, vacuities, liver and kidney dysfunctions and heart failure class 3.
Exclusion criteria: wound with active infection that needs antibiotic therapy and any gangrene wound that needs amputation; any evidence of ischemic, traumatic, neurotropic and venous ulcers; procrastinate refer to diabetes clinic for wound dressing change more than two times.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
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
Ahvaz Jundishapor University of Medical Sciences Ethics Committee
Street address
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Khozestan.
City
Ahvaz
Postal code
Approval date
2014-05-31, 1393/03/10
Ethics committee reference number
ajums.REC.1393, 61
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
1
Description
Tissue around the wound
Timepoint
Weekly
Method of measurement
Based on diabetic foot ulcers check list
2
Description
Wound degree
Timepoint
Weekly
Method of measurement
Based on diabetic foot ulcers check list
3
Description
Wound exudates
Timepoint
Weekly
Method of measurement
Based on diabetic foot ulcers check list
4
Description
Wound color
Timepoint
Weekly
Method of measurement
Based on diabetic foot ulcers check list
Intervention groups
1
Description
In the intervention group, wound and tissues around the wound is placed in sterile saline container for 20 minutes and then dry with sterile gaze.Then 2 cc of olive oil will pour in the wound in a way that cover the entire surface of the wound. Then the wound would be dressed with a layer of gaze with sterile technique. This procedure will do once in a day,and seven days of a week for 1 month.
Category
Treatment - Drugs
2
Description
In the control group, wound and tissues around the wound is placed in sterile saline container for 20 minutes and then dry with sterile gaze.Then the wound would be dressed with a layer of gaze with sterile technique. This procedure will do once in a day,and seven days of a week for 1 month.