Is turmeric preparation effective on diabetic foot sore
Design
study includes 30 patients, 15 as control and 15 as intervention. it is open-label and phase 4 trial.
Settings and conduct
As diabetes has a huge burden and complications, to find alternative, more effective and less expensive methods is an appropriate action. this study is done in Modarress hospital of saveh and Mostafa Khomini dispensery. study designed in two parallel groups, one as control and the other as intervention group.
Participants/Inclusion and exclusion criteria
inclusion criteria: patients with diabetic foot sore
exclusion criteria: patients with osteomyelitis
Intervention groups
turmeric ointment applied on sores twice daily after washing with saline for 5 weeks. saline washing applied for control group. all sores dressed by sterile gauze.
Main outcome variables
1) clinical variables: A) signs of diabetic sore(s) B) area of the sore(s)
2) laboratory variables: A) FBS B) BS 2h PP C) HgA1C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170828035960N2
Registration date:2019-02-05, 1397/11/16
Registration timing:registered_while_recruiting
Last update:2019-02-05, 1397/11/16
Update count:0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
sasan gazerani
Name of organization / entity
Saveh universty of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 4234 3395
Email address
s_gazerani@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ٍّEffect of turmeric dressing on diabetic foot in comparison to routine dressing
Public title
Turmeric and diabetic sore
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with diabetic foot sore
no sign of osteomyelitis
Exclusion criteria:
osteomyelitis
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
29
Randomization (investigator's opinion)
N/A
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 saveh university of medical sciences
diabetic foot ulcer in prolonged and uncontrolled diabetes mellitus
ICD-10 code
E08.51
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy without gangrene
2
Description of health condition studied
diabetic foot ulcer in prolonged and uncontrolled diabetes mellitus
ICD-10 code
E10.51
ICD-10 code description
Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene
3
Description of health condition studied
diabetic foot ulcer in prolonged and uncontrolled diabetes mellitus
ICD-10 code
E11.51
ICD-10 code description
Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene
Primary outcomes
1
Description
Any probable changes in the size of diabetic foot sore by using imageJ software.
Timepoint
weekly measurement of the size of the sore for 5 consecutive week
Method of measurement
by image J software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: in this group we study effect of turmeric ointment (manufactured by seagull compoany) on diabetic foot. According to previous studies we apply this ointment twice daily for 5 consecutive weeks. Usage of this ointment is in addition to standard protocols using for the patients. After irrigation of the wound by normal saline wound will be covered by turmeric dressing. previous medications will be continued according to the physician decision.
Category
Treatment - Drugs
2
Description
Control group: In control group, wound only will be irrigated by normal saline then dressed and administered medication will be continued.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Moddares general hospital-Saveh
Full name of responsible person
Sasan Gazerani
Street address
Yas str., Kaveh industrial city, saveh
City
Saveh
Province
Markazi
Postal code
3914334911
Phone
+98 86 4234 3395
Fax
+98 86 4234 2137
Email
s_gazerani@hotmail.com
Web page address
http://isid.research.ac.ir/Sasan_Gazerani
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Farideh Rahnama
Street address
Yas str., Kaveh industrial city
City
Saveh
Province
Markazi
Postal code
3914334911
Phone
+98 86 4234 3395
Fax
+98 86 4234 2137
Email
s_gazerani@hotmail.com
Web page address
http://isid.research.ac.ir/Sasan_Gazerani
Grant name
Grant code / Reference number
96_01_29
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Saveh 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
Saveh University of Medical Sciences
Full name of responsible person
Sasan Gazerani
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Yas str., Kaveh industrial city
City
Saveh
Province
Markazi
Postal code
3914334911
Phone
+98 86 4234 2137
Fax
+98 86 4234 2137
Email
s_gazerani@hotmail.com
Web page address
http://isid.research.ac.ir/Sasan_Gazerani
Person responsible for scientific inquiries
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Sasan Gazerani
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
pain
Street address
Yas str., Kaveh industrial state
City
Saveh
Province
Markazi
Postal code
3914334911
Phone
+98 86 4234 3395
Fax
+98 86 4234 2137
Email
s_gazerani@hotmail.com
Web page address
http://isid.research.ac.ir/Sasan_Gazerani
Person responsible for updating data
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Sasan Gazerani
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Yas str., Kaveh industrial city
City
Saveh
Province
Markazi
Postal code
3914334911
Phone
+98 86 4234 3395
Fax
+98 86 4234 2137
Email
s_gazerani@hotmail.com
Web page address
http://isid.research.ac.ir/Sasan_Gazerani
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is 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
after deidentifying patients, data could be shared.
When the data will become available and for how long
after completing the research data would become availabe.
To whom data/document is available
it will be available for people working in academic institutions and also foor people working in drug industries sector.
Under which criteria data/document could be used
using the result for treatment of patients and also in pharmaceutical industries is recommended.
From where data/document is obtainable
call corresponding author.
What processes are involved for a request to access data/document
correspond to vice-chancellor in research affairs in saveh university of medical sciences.