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IRCT20230409057860N1 IRCT 2023-05-20 Ghoum University of Medical Sciences Investigating the effectiveness of the extract of the case compared to the conventional treatment (according to the protocol) in the treatment of diabetic foot ulcers after cutting in patients referred to Shahid Beheshti Hospital in Qom in 2023 Investigating the effectiveness of the extract of the case compared to the conventional treatment (according to the protocol) in the treatment of diabetic foot ulcers after cutting in patients referred to Shahid Beheshti Hospital in Qom in 2023 2023-05-22 anticipated 40 Complete https://irct.ir/trial/69523 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the random block sampling method will be used. The block randomization method is one of the randomization methods in order to balance the number of samples in each of the treatment groups while maintaining randomization. In this study, randomization method with fixed block size (size of each block is 4) has been used, for example AABB or BAAB block (A and B are the groups under study) that the way of allocating people and forming blocks using The output of the R software will be generated. This sampling method provides the possibility of performing intermediate analyzes with equal sample size in each group. 1-2 Diabetic foot ulcer. Intervention 1: Intervention group: It is a group that will be treated with a combination of medicinal plants in addition to treatment and routine care. Intervention 2: Control group: It is a group that has undergone routine treatment after surgery. Yes - There is a plan to make this available What will be shared: All the data will be published in the article and thesis after removing the names of the patients When: 3 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: For scientific research Where to obtain: Ehsan Sahbaei e24267s@gmail.com How to obtain: Submit an academic application and a description of your study and the need for data for this study Comments:
public Ehsan Sahbaei
Qom University of Medical Sciences
Qom Iran (Islamic Republic of) 3713649373 +98 25 3107 0100 e24267s@gmail.com Ghoum University of Medical Sciences scientific Ehsan Sahbaei
Qom University of Medical Sciences
Qom Iran (Islamic Republic of) 3713649373 +98 25 3107 0100 e24267s@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients with type 2 diabetes, men and women in the age range of 30 to 80 years, with multiple or single wounds that have been debrided. The wound of the patient in both groups is completely debrided before dressing so that no infection is observed. After debridement and washing the wound with water, the control group is given a normal dressing. 30 years 80 years Both Acute diabetic foot ulcer, grade 3, 4, and 5 diabetic foot ulcer, drug and alcohol abuse; Suffering from a chronic disease other than diabetes that affects the wound healing process, such as severe vascular diseases, lupus, rheumatoid arthritis, Berger's and kidney failure, taking drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents. , and sensitivity to herbal medicines used in the plan Treatment - Drugs Treatment - Drugs Intervention group: It is a group that will be treated with a combination of medicinal plants in addition to treatment and routine care Control group: It is a group that has undergone routine treatment after surgery Diabetic foot ulcer treatment. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14, 21, 28, 35, 42, 56 days after the start of the intervention. Method of measurement: A standard ruler is placed on the side of the wound and by taking a digital photograph of the leg wound, the area of the wound will be calculated with the above standard scale in square centimeters by means of the exclusive area measurement software. Ghoum University of Medical Sciences Approved 2023-01-30 Ethics Committee of Qom University of Medical Sciences Qom University of Medical Sciences qom Ghoum Iran (Islamic Republic of)