Protocol summary
-
Study aim
-
Determination and comparison of the effects of oral and topical propolis on the area of foot ulcer, leukocyte count, pathogenic bacteria, total antioxidant capacity and malondialdehyde
-
Design
-
In this trial, 80 patients with diabetic foot ulcers with Grade 1 and 2, which are based on the University of Texas Foot Wound Classification System, are only being studied for standard and common treatment. Qualified individuals will be randomly assigned to four groups using the random numbers table.
-
Settings and conduct
-
This study is a clinical trial. In this trial, diabetic patients with diabetic foot ulcers referred to Shahid Beheshti Clinic of Qom University of Medical Sciences are enrolled. Then, 80 patients were randomly assigned to four intervention and control groups.
-
Participants/Inclusion and exclusion criteria
-
Diabetic people with foot ulcer
-
Intervention groups
-
First intervention group: Three capsules of 500 mg of propolis (daily), Second intervention group: Propolis ointment (1.5 g daily), Third intervention group: Propolis (1500 mg daily) and propolis Ointment (1.5 g daily), Control group: Regular foot wound treatment includes washing with serum physiology
-
Main outcome variables
-
Area of foot ulcer, leukocyte count, pathogenic bacteria
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2017040419669N3
Registration date:
2017-04-15, 1396/01/26
Registration timing:
registered_while_recruiting
Last update:
2018-05-02, 1397/02/12
Update count:
1
-
Registration date
-
2017-04-15, 1396/01/26
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for research, Qazvin University of Medical Sciences
-
Expected recruitment start date
-
2017-04-04, 1396/01/15
-
Expected recruitment end date
-
2017-05-22, 1396/03/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Compare the effects of oral propolis with topical propolis on diabetic foot ulcer
-
Public title
-
Effects of propolis on diabetic foot ulcer
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients with diabetic foot ulcers grade 1 and 2
Willingness to cooperate
Exclusion criteria:
Patients with wounds functions deep grade and step higher than 1 and 2
Sensitivity to topical formulation
-
Age
-
From 18 years old to 75 years old
-
Gender
-
Both
-
Phase
-
2-3
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
80
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Simple randomization
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-02-27, 1395/12/09
-
Ethics committee reference number
-
IR.QUMS.REC.1395.294
Health conditions studied
1
-
Description of health condition studied
-
Diabetic food ulcers
-
ICD-10 code
-
L97
-
ICD-10 code description
-
Ulcer of lower limb, not elsewhere classified
Primary outcomes
1
-
Description
-
Area of diabetic foot ulcers
-
Timepoint
-
The beginning and End of the study
-
Method of measurement
-
With AutoCAD software
2
-
Description
-
Average leukocytes in diabetic foot ulcers
-
Timepoint
-
The beginning and End of the study
-
Method of measurement
-
The sampling
3
-
Description
-
The number of pathogenic bacteria
-
Timepoint
-
The beginning and End of the study
-
Method of measurement
-
The Sampling and culture
4
-
Description
-
Total Antioxidant Capacity
-
Timepoint
-
The beginning and End of the study
-
Method of measurement
-
Eliza kit
5
-
Description
-
ُserum Malondialdehyde
-
Timepoint
-
The beginning and End of the study
-
Method of measurement
-
Eliza kit
Intervention groups
1
-
Description
-
Control group : Rinse with saline daily
-
Category
-
Treatment - Drugs
2
-
Description
-
Intervention group 3: 1500 mg Propolis ointment for topical use on the ulcer and 1500 mg Propolis capsules (three 500 mg capsules), daily for 4 weeks.
-
Category
-
Treatment - Drugs
3
-
Description
-
Intervention group 2: 1500 mg Propolis ointment for topical use on the ulcer, daily for 4 weeks.
-
Category
-
Treatment - Drugs
4
-
Description
-
Intervention group 1: Propolis capsules, 1500 mg(three 500 mg capsules), daily for 4 weeks.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
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, Qazvin 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
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
-
No - There is not 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
-
Yes - There is a plan to make this available
-
Title and more details about the data/document
-
Data on primary and secondary outcomes will be published.
-
When the data will become available and for how long
-
After completing the study and analyzing the data
-
To whom data/document is available
-
All researchers
-
Under which criteria data/document could be used
-
There is no objection to the use of data provided the source of the resource.
-
From where data/document is obtainable
-
IRCT site
-
What processes are involved for a request to access data/document
-
There is no objection to the use of data provided the source of the resource.
-
Comments
-