The aim of this study is the evaluation of Honey effect on wound healing in diabetic foot. This study population included all patients admitted to Sari Hekmat hospital with diabetic foot. Inclusion criteria include having diabetic foot type 2 and 3 and the absence of vascular disease and exclusion criteria are rheumatoid arthritis, vasculitis, chemotherapy, immunosuppressive and steroid drugs. Data will be collected using list. wound will be assessed whit a list include grade, depth and length of lesion, pain severity, infection and the type of microorganisms before study and at the end of the first, second and third week after intervention. Debridement will be performed for all patients that are required by orthopedic surgeon under general or regional anesthesia. Daily dressing will be performed after washing the wound with normal saline. Then with a piece of gauze that is about 2 cm larger than the size of the wound , honey will be applied , and the wound will be dressing. In the control group after washing the wound with normal saline, a layer of sock gauze will be applied on wound and with minimal pressure the wound will be bandaged. Wound dressing will be done daily with a trained nurse and control of it's recovery will be followed by orthopedic surgeon. At the end of the first, second and third week wound will be assessed. Data will be analyzed using SPSS software version 16.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402207494N8
Registration date:2014-05-26, 1393/03/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-26, 1393/03/05
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran.
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial the effect of spring honey on healing of foot ulcer in diabetic patients
Public title
Honey on healing of foot ulcer in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ulcer diabetic type 2 and 3 ; absence of vascular disease
Exclusion criteria; rheumatoid arthritis, vasculitis, chemotherapy, immunosuppressive and steroid drugs drugs affecting the nerves and blood vessels, such as anticonvulsants and anti-arrhythmias
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Mazandaran University of Medical Sciences
Street address
Ethics Committee of Mazandaran University of Medical Scienc, Imam Square, Highway Bassij, 3-way Jouibar, Sari, Mazandaran
City
Sari
Postal code
4815696869
Approval date
2014-02-20, 1392/12/01
Ethics committee reference number
490
Health conditions studied
1
Description of health condition studied
diabetic foot ulcer
ICD-10 code
(I79.2*)
ICD-10 code description
Diabetic peripheral angiopathy
Primary outcomes
1
Description
Diiabetic foot ulcer
Timepoint
Befor study and at the end of the first, second and third week after intervention
Method of measurement
Researcher made list
Secondary outcomes
1
Description
Gangrene or amputation
Timepoint
Every day until the end of the study
Method of measurement
َAssesment and report by a specialist nurse
Intervention groups
1
Description
In experimental group daily dressing will be performed after washing the wound with normal saline. Then with a piece of gauze that is about 2 cm larger than the size of the wound, honey will be applied, and the wound will be dressed. Spring honey that will be used in this study approved by food laboratory of Mazandaran University of Medical Sciences as PH, amount of Froctos and absence of micro-organisms .
Category
Treatment - Drugs
2
Description
In the control group after washing the wound with normal saline, a layer of sock gauze will be applied on wound and with minimal pressure the wound will be bandaged. Wound dressing will be done daily with a trained nurse and control of it's recovery will be followed by orthopedic surgeon.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Hekmat hospital
Full name of responsible person
Dr Masumeh Bagheri Nesami
Street address
School of Nursing & Midwifery, Vessal street, Sciences, Sari, Iran.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran..
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Attieh Nikkhah
Position
Master in critical care nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Vessal street, Sciences, Sari, Iran.
City
Sari
Postal code
4815696869
Phone
+98 15 1227 1010
Fax
Email
atinik1357@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Social security organization
Full name of responsible person
Dr Shohre Pirzadeh
Position
Specialist in Orthopedics
Other areas of specialty/work
Street address
Hekmat hospital, Taleghani Ave,Sari, Iran.
City
Sari
Postal code
4815696869
Phone
+98 32 68923
Fax
Email
atinik1357@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)