The aim of the study is to determine the effect of ozone therapy, honey dressing and combination of ozone and honey dressing on healing of diabetic foot ulcer
Design
A clinical trial with a community-based, practice-oriented control group, with parallel groups, not blinding. Randomized random block method
Settings and conduct
The research sample size consists of 140 patients with diabetic foot(intervention group 105, control group 35) in Imam Reza hospital in Kermanshah city in 2017-2019
Participants/Inclusion and exclusion criteria
The inclusion criteria: Physician and patient satisfaction
Age over 18
Do not use corticosteroid during the past month
Do not use immunosuppressive drugs
Lack of osteomyelitis
Lack of smoking
Insensitivity to honey and ozone therapy
exclusion criteria:
unwillingness to cooperate
Unwillingness to co-operate with a patient or physician
Severe infection (Grade 4 system of the podium)
Prescription Drugs Suppressing the Immune System and Corticosteroids
Amputation
Death
Intervention groups
The intervention in this study is using the 405 honey(The brand of this dress is Made Honey, produced by the Austrian Hartmann Company), Ozone therapy with a Mead device, (produced by Germany). there is no intervention in the control group. The wound examination is performed by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study.
Main outcome variables
healing of diabetic foot ulcer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181105041563N3
Registration date:2018-12-18, 1397/09/27
Registration timing:prospective
Last update:2018-12-18, 1397/09/27
Update count:0
Registration date
2018-12-18, 1397/09/27
Registrant information
Name
Somayeh Mahdavikian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
somayeh.mahdavikian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the effect of ozone therapy, honey dressing and combination of ozone and honey dressing on healing of diabetic foot ulcer
Public title
Comparative study on the effect of ozone therapy, honey dressing and combination of ozone and honey dressing on healing of diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Physician and patient satisfaction
Age over 18
Do not use corticosteroid during the past month
Do not use immunosuppressive drugs
Lack of osteomyelitis
Lack of smoking Insensitivity to honey and ozone therapy
Exclusion criteria:
Unwillingness to co-operate with a patient or physician
Severe infection (Grade 4 system of the podium)
Prescription Drugs Suppressing the Immune System and Corticosteroids
Amputation
Death
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Qualified samples were entered into the study by accessible method and randomly divided into intervention groups (Honey, Ozone and Honey-ozone) and control. Blocks were done as follows: To dressing groups with Honey, Ozone and Honey-ozone was assigned A ، B and C codes respectively, and the control group received D code. The study blocks were ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, and the ABCD block was selected as the first block. Patients were assigned to Honey,ozone ,Honey-ozone, and control groups, respectively, and this method continued until the samples were completed.
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 Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Approval date
2018-08-14, 1397/05/23
Ethics committee reference number
IR.KUMS.REC.1397.496
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
healing of diabetic foot ulcer
Timepoint
One week after starting treatment, two weeks after starting treatment and at the end of the study
Method of measurement
Wagner ,pedis and beta johnson scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1: Wound, dressed daily, up to 8 weeks, with 405 honey. The brand of this dress is Mede Honey, produced by the Austrian Hartmann Company, wound healing by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study.
Category
Treatment - Other
2
Description
Intervention group: Group Two: Ozone therapy will be performed in eight weeks (16 times) with a Mead device, produced by Germany. Wound examination by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after Start treatment and at the end of the study.
Category
Treatment - Other
3
Description
Intervention group: Group 3: In addition to ozone therapy, honey dressing will also be done for 8 weeks. The wound examination is performed by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study.
Category
Treatment - Other
4
Description
Group 4: In the control group, only routine treatments will be performed. Includes daily washing, debridement, gas dressing and antibiotic therapy (based on prescribing physician). The wound examination is performed by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Somayeh Mahdavikian
Street address
Imam Reza hospital, Baghe abrisham
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
address Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
676715987479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kkums.ac.ir
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, Kermanshah 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
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Somayeh Mahdavikian
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Somayeh Mahdavikian
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Somayeh Mahdavikian
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available