Protocol summary

Summary
The aim of this randomized double blind trial is to compare the effect of standard treatment with turmeric pomade on healing of diabetic foot ulcer. In this study, 50 diabetic patients having inclusion criteria will be randomly placed in the intervention or control group. The patients in the intervention group will receive turmeric, one applicator daily for a year. The patients in the control group, however, will receive placebo in a similar dose and shape. To evaluate response to treatment, we will consider the grade and diameter of the wound.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012315513N1
Registration date: 2011-10-09, 1390/07/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-09, 1390/07/17
Registrant information
Name
Rahman Khosravi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1544 1336
Email address
khosravir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of standard treatment with turmeric pomade on healing of diabetic foot ulcers
Public title
Comparing effect of standard treatment with turmeric pomade on healing of diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diabetes types 1 and 2 under insulin therapy; Age between 18-75 years old; Open wound without healing under treatment for more than 2 weeks without response Exclusion Criteria: Severe heart failure; Cardiac arrhythmia; Pulselessness; Conditions preventing wound healing such as cellulitis, renal failure and dialysis patients, Severe hepatic failure, Immunosuppressive therapy, Radiotherapy, chemotherapy, varicose
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: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciencesو, Golgasht Street, Tabriz, IRAN
City
Tabriz
Postal code
5166614756
Approval date
2011-06-18, 1390/03/28
Ethics committee reference number
5/4/2445

Health conditions studied

1

Description of health condition studied
Diabetes Mellitus
ICD-10 code
E10, E11,
ICD-10 code description
Insulin-dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus, Malnutrition-related diabetes mellitus, Other specified diabetes mellitus, Unspecified diabetes mellitus

Primary outcomes

1

Description
Wound healing
Timepoint
Over a year
Method of measurement
Decline of wound grade (Wound depth reduction)

Secondary outcomes

empty

Intervention groups

1

Description
An applicator of Turmeric pomade, daily for a year
Category
Treatment - Drugs

2

Description
An applicator of placebo pomade, daily for a year
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina educational and therapeutic Hospital
Full name of responsible person
Dr. Hemmat Maghsoudi
Street address
Sina Hostpital, Azadi Street, Tabriz, IRAN
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr. Hemmat Maghsoodi
Street address
Sina Hospital, Azadi Street, Tabriz, IRAN
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sina Hospital
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hemmat Maghsoudi
Position
General surgeon, Professor
Other areas of specialty/work
Street address
Sina Hospital, Azadi Street, Tabriz, IRAN
City
Tabriz
Postal code
5163639888
Phone
+98 41 1541 2101
Fax
Email
maghsoudih@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hemmat Maghsoudi
Position
General surgeon, Professor
Other areas of specialty/work
Street address
Sina Hospital, Azadi street, Tabriz, IRAN
City
Tabriz
Postal code
5163639888
Phone
+98 41 1541 2101
Fax
Email
maghsoudih@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hemmat Maghsoudi
Position
General surgeon, Professor
Other areas of specialty/work
Street address
Sina Hospital, Azadi street, Tabriz, Iran
City
Tabriz
Postal code
5163639888
Phone
+98 41 1541 2101
Fax
Email
maghsoudih@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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