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IRCT201105236565N1 IRCT 2011-07-06 Vice chancellor for research, Kermanshah University Of Medical Sciences and Health Services Determination of the efficacy of artemisia extraction dressing on the healing of diabetic foot ulcer Comparison of healing effect of aqueous extract from one Artemisia spp on diabetic foot ulcer with classic treatment: a clinical trial. 2010-11-22 anticipated 18 Complete https://irct.ir/trial/7009 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Diabetic foot. Intervention 1: 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. Intervention 2: 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.
public Dr Gholam Reza Bahrami
pharmacy faculty, kermanshah, Iran.
Kermanshah Iran (Islamic Republic of) +98 83 1428 1562 gbahrami@kums.ac.ir Kermanshah University of Medical Science scientific Dr Mehr Ali Rahimi
Diabetic Research Ceter, Beheshti Blv, Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) +98 83 1838 7027 m.javadra@kums.ac.ir Kermanshah University of Medical Science Iran (Islamic Republic of) 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. 18 years 75 years Both E10, E11, Diabetes mellitus Treatment - Drugs Treatment - Drugs 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. 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. Diameter reduction rate. Timepoint: Weekly for 2 months. Method of measurement: Evaluation of diameter with precise measurement with digital photo. Percentage of complete healing. Timepoint: Weekly for 8 week. Method of measurement: Evaluation of percentage of complete healing with precise measurement with Digital photo. Vice chancellor for research, Kermanshah University Of Medical Sciences and Health Services Approved 2010-08-20 Ethical committe of Kermanshah University of Medical Sciences and Health Services Beheshti blv, Kermanshah, Iran Kermanshah Iran (Islamic Republic of)