]>
IRCT20200325046854N3 IRCT 2023-10-28 Iran University of Medical Sciences topical simvastatin in diabetic foot ulcer Evaluating the effect of topical simvastatin 2% ointment on the healing of diabetic foot ulcer in comparison with the routine treatment 2023-11-16 anticipated 60 Complete https://irct.ir/trial/73248 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Among the patients referred to the clinic or hospitalized in Rasoul Akram Hospital, numbering is done in odd and even numbers. Odd patients will be in the treatment group and even patients will be in the control group, Blinding description: The participant does not know the type of treatment. 1 diabetic foot ulcer. Intervention 1: Intervention group:Patients in Rasoul Akram Hospital, diagnosed with Wagner grade 2 diabetic foot ulcer, will be treated with simvastatin 2% ointment. Ointment will be administered twice a day for 2 weeks and the wound will be covered with Vaseline gauze. Intervention 2: Control group: Patients in Rasoul Akram Hospital, diagnosed with Wagner grade 2 diabetic foot ulcer, will be treated with Simple foam dressing for 2 weeks and twice a day. Yes - There is a plan to make this available What will be shared: As an article When: 8 months after the end of the study To whom: Researchers and specialist in academic and scientific institutions Conditions: In case of a written request to the study authorities and while preserving the copyright, patient data will be made available to applicants. Where to obtain: Maryam Farasatinasab, Assistant Professor of Clinical Pharmacy, Iran University of Medical Sciences. Email: maryfarasati@gmail.com How to obtain: At the formal request to the person in charge of study Comments:
public Fatemeh Jamali
School of Pharmacy and Pharmaceutical Sciences - Islamic Azad University, Gholhak, Shariati St
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 0051 fateme_jamali77@yahoo.com Islamic Azad University scientific Maryam Farasatinasab
Firoozgar Hospital, Beh Afarin St.,Karim Khan Zand St.,Valiasr Square
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1558 maryfarasati@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) A patient with Wagner grade 2 diabetic foot ulcer Not using topical antibiotics for the patient A patient with no symptoms of septicemia, septic shock or organ dysfunction syndrome The age of the patient should not be less than 18 years and not more than 70 years. 18 years 70 years Both Receive other topical treatments for diabetic foot ulcers E08.621 Diabetes mellitus due to underlying condition with foot ulcer Treatment - Drugs Treatment - Drugs Intervention group:Patients in Rasoul Akram Hospital, diagnosed with Wagner grade 2 diabetic foot ulcer, will be treated with simvastatin 2% ointment. Ointment will be administered twice a day for 2 weeks and the wound will be covered with Vaseline gauze. Control group: Patients in Rasoul Akram Hospital, diagnosed with Wagner grade 2 diabetic foot ulcer, will be treated with Simple foam dressing for 2 weeks and twice a day. Grading the type and severity of the wound. Timepoint: Day 0, 7 and 14. Method of measurement: The size, amount of discharge and smell of the wound. Evaluating the apparent progress of wound healing. Timepoint: Day 0, 7 and 14. Method of measurement: Imaging. Possible side effects. Timepoint: Day 0, 7 and 14. Method of measurement: Descriptive. Iran University of Medical Sciences Approved 2023-01-02 Research Ethics Committees of Islamic Azad Tehran Medical Sciences University - Pharmacy and Pharmac shariati St, Gholhak Tehran Tehran Iran (Islamic Republic of)