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IRCT20240927063181N1 IRCT 2024-09-29 Esfahan University of Medical Sciences Comparison of healing rate of diabetic foot ulcer between two groups of dressing with ointment containing turmeric root extract and dressing with placebo in diabetic patients Comparison of healing rate of diabetic foot ulcer between two groups of dressing with ointment containing turmeric root extract and dressing with placebo in diabetic patients 2024-10-01 anticipated 72 Complete https://irct.ir/trial/79226 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This stage will be Randomized Block Design. At this stage, patients will be divided into 2 blocks (36 blocks of 2). Then they are sorted according to the national code (the larger national code of the first row of the block and the smaller national code of the second row of the block). After that, we refer to the table of random numbers for each block. If the selected number was from 0 to 4, the patient in the first row will join group A and the patient in the second row will join group B. If the selected number was from 5 to 9, the patient in the first row will join group B and the patient in the second row will join group A. After 36 patients in group A and 36 patients in group B are determined, the clinical pharmacologist, who is blinded to the selected patients, determines which group each of groups A and B will receive curcumin ointment or dressing. be with placebo ointment, Blinding description: The placebo ointment looks exactly like the curcumin ointment, but it is filled with eucerin. Therefore, the researcher, the patient, and the data analyst are not aware of the type of ointment used, and only the data collector who is a trained clinical caregiver is aware of it. 2-3 Diabetic foot ulcer. Intervention 1: Intervention group: In the dressing group with curcumin ointment, the diabetic foot wound will be dressed once a day by a wound expert after washing with normal saline using an ointment containing turmeric root extract (so as to cover the wound). Intervention 2: Control group: In the diabetic foot wound dressing group with placebo ointment, after usual washing with normal saline and routine treatment based on the TIME model, placebo ointment, which is completely similar to curcumin ointment in appearance, but filled with eucerin, will be used on the wound and then bandaged. Eucerin's main topical product is a moisturizer that contains petrolatum, lanolin, mineral oil, and dimethicone as primary emollients, and glycerin, lecithin, and propylene glycol as secondary moisturizers. No - There is not a plan to make this available Justification or reason for not sharing IPD is Information is kept confidential.
public Gholamali Hoghooghi
Al-Zahra hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 gholamalihoghooghi@gmail.com Esfahan University of Medical Sciences scientific Gholamali Hoghooghi
Al-Zahra hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 gholamalihoghooghi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetes Diabetic foot ulcer grade 3 or lower (grades 1, 2 and 3) according to "Wagner-Meggitt's" criteria Informed consent to participate in the study no limit no limit Both Using other methods of treating diabetic foot ulcers, such as leech therapy, etc Heavy smoker patients Patients with morbid obesity (BMI>40) Patients with vascular insufficiency Z86.31 Personal history of diabetic foot ulcer Treatment - Drugs Treatment - Drugs Intervention group: In the dressing group with curcumin ointment, the diabetic foot wound will be dressed once a day by a wound expert after washing with normal saline using an ointment containing turmeric root extract (so as to cover the wound). Control group: In the diabetic foot wound dressing group with placebo ointment, after usual washing with normal saline and routine treatment based on the TIME model, placebo ointment, which is completely similar to curcumin ointment in appearance, but filled with eucerin, will be used on the wound and then bandaged. Eucerin's main topical product is a moisturizer that contains petrolatum, lanolin, mineral oil, and dimethicone as primary emollients, and glycerin, lecithin, and propylene glycol as secondary moisturizers. Grading of diabetic foot ulcers. Timepoint: The end of the first and second weeks after the start of treatment. Method of measurement: "Wagner-Meggitt's" criteria. Esfahan University of Medical Sciences Approved 2023-12-26 Ethics committee of Isfahan University of Medical Sciences Vice Chancellor for Research and Technology, Hezar Jerib St.sfahan University of Medical Sciences and Health Services, Building No. 4 Isfahan Isfehan Iran (Islamic Republic of)