This study is a clinical trial to evaluate the effects of oral propolis supplement and topical propolis treatment on diabetic foot ulcers. In this randomized trial, 80 patients with diabetic foot ulcers grade 1 and 2, based on the University of Texas Foot Wound Classification System who are under the standard treatment, will be included. Eligible patients will randomly be divided into four groups using a table of random numbers. The first group will receive oral capsules containing five hundred milligram propolis, 3 times a day. The second group will receive propolis ointment, 1.5 g a day. Group 3 will receive both Propolis oral capsule and Propolis ointment and Group IV will receive conventional treatment of diabetic foot ulcers including rinse with saline daily. In this study, diabetic foot ulcer area, the leukocytes and pathogenic bacteria present in the wound are the main outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040419669N3
Registration date:2017-04-15, 1396/01/26
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-04-15, 1396/01/26
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
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: willingness to cooperate; patients with diabetic foot ulcers grade 1 and 2 based on the University of Texas Foot Wound Classification System.
Exclusion criteria: patients with wounds functions deep grade and step higher than 1 and 2; patients under other treatments; 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
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 Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
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
Secondary outcomes
empty
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Metabolism and Endocrinology clinic martyr Beheshti Hospital in Qom
Full name of responsible person
Dr. Hossein Khadem Haghighian
Street address
Qazvin University of Medical Sciences, Shahid Bahonar blvd.
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Position
Ph.D in Nutrition
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3732 7650
Fax
Email
khademnut@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Position
Ph.D in Nutrition
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3732 7650
Fax
Email
khademnut@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Hossein Khadem Haghighian
Position
Assistant Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3732 7650
Fax
Email
khademnut@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)