In a randomized clinical trial, healing effect of a herbal extract from Artemisia spp on diabetic foot ulcer is studied. Eighteen diabetic patient (type 1 or 2), between the age of 18-75 years, from either sex, who have Grade<3 Wagner classification diabetic foot ulcer, and with out "evidence of systemic or local infection such as purulent drainage and osteomyelitis;erythema in the edge of wound with 3 centimeter width and exposed bone at the wound site;sever and chronic ischemia of lower limb with out presence of pulsation;foot gangrene such that a surgical treatment is required", randomly allocated in test or control groups. The test group will receive topical Artemisia extract, while classic treatment including cleaning of the wounds, renewal of the dressing and antibiotic therapy is perform in the control group. Healing of the wounds is monitored carefully using direct observation by the physician and digital photography. The images will be sort based on date of photography and area of the wounds as well as their healing rate will be calculated using Auto-CAD soft ware.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105236565N1
Registration date:2011-07-06, 1390/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-06, 1390/04/15
Registrant information
Name
Gholam Reza Bahrami
Name of organization / entity
Kermanhsah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1428 1562
Email address
gbahrami@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, kermanshah University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of healing effect of aqueous extract from one Artemisia spp on diabetic foot ulcer with classic treatment: a clinical trial.
Public title
Determination of the efficacy of artemisia extraction dressing on the healing of diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of diabetic foot ulcer in type 1 or 2 diabetes mellitus patient;age between 18 and 75 years with diabetic foot ulcer;The ulcer of the the patients have been caused by peripheral neuropathy; uncontrolled hyperglycemia;trauma; diabetic foot ulcers which remained open without healing and/or improvement for at least 2 week;Patients should be available for 2 months and to be able to adhere to the treatment regime. Exclusion criteria:patients with ≥Grade III Wagner classification diabetic foot ulcers;evidence of systemic or local infection such as purulent drainage and osteomyelitis; erythema in the edge of wound with 3 centimeter width and exposed bone at the wound site; sever and chronic ischemia of lower limb without presence of pulsation;simultaneous diseases which had impact on healing process such as vasculitis or different types of cancers;hepatic or renal failure;endocrine;hematological or immunologic disorder;past history of/current acute or chronic autoimmune disease;chronic alcohol or drug abuse;immunosuppressive drugs;cytotoxic agents;radiation therapy and chemotherapy were excluded.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
18
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
Ethical committe of Kermanshah University of Medical Sciences and Health Services
Street address
Beheshti blv, Kermanshah, Iran
City
Kermanshah
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
7/420/1900321
Health conditions studied
1
Description of health condition studied
Diabetic foot
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Diameter reduction rate
Timepoint
Weekly for 2 months
Method of measurement
Evaluation of diameter with precise measurement with digital photo
Secondary outcomes
1
Description
Percentage of complete healing
Timepoint
Weekly for 8 week
Method of measurement
Evaluation of percentage of complete healing with precise measurement with Digital photo
Intervention groups
1
Description
The test group will receive topical Artemisia extraction, twice a day, and follow up weekly for 2months or until the complete healing of the wounds. Evaluation of diameter, percentage of healing and mean duration of healing calculated with digital photos and Auto CAD soft ware.
Category
Treatment - Drugs
2
Description
The control group will received classic treatments for diabetic foot ulcer, and follow up weekly for 2 months or until the complete healing the wound. Evaluation of diameter, percentage of healing and mean duration of healing calculated with digital photos and Auto CAD soft ware.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic Research Center in Kermanshah
Full name of responsible person
Dr Mehr Ali Rahimi
Street address
Beheshti Blv, Kermanshah, Iran
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University Of Medical Sciences and Health Services
Full name of responsible person
Dr Farid Najafi
Street address
Kermanshah University Of Medical Sciences, Beheshti blv, kermanshah, iran
City
Kermanshah
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 and Health Services
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
Kermanshah University of Medical Science
Full name of responsible person
Dr Gholam Reza Bahrami
Position
Professor
Other areas of specialty/work
Street address
pharmacy faculty, kermanshah, Iran.
City
Kermanshah
Postal code
Phone
+98 83 1428 1562
Fax
Email
gbahrami@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Dr Mehr Ali Rahimi
Position
Associate Professor
Other areas of specialty/work
Street address
Diabetic Research Ceter, Beheshti Blv, Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 1838 7027
Fax
Email
m.javadra@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Saeedeh Malek Hosseini
Position
pharmacy student
Other areas of specialty/work
Street address
No.8, Pasdaran street, Songhor, Kermanshah,Iran
City
Songhor
Postal code
Phone
+98 83 8422 2637
Fax
Email
saeedeh_mj@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)