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IRCT20080904001199N4 IRCT 2020-10-05 Darudarman Salafchegan Co. (Knowledge-based) Dermaheal Effect on Diabetic Foot Ulcer SDWHE Evaluation of Dermaheal Ointment Healing Effects on Diabetic Foot Ulcer: Double-Blind Randomized Clinical Trial Study 2020-10-22 anticipated 50 Complete https://irct.ir/trial/51263 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: No, Randomization description: The first step in the random process is to create a random sequence. The second step after creating a random sequence is to hide the generated sequence. To use the random number table, we must first determine the number of the table to read. The second is to consider numbers for different groups (for example, pair numbers for intervention A and individual numbers for intervention B, then hand over one of the numbers and move in one of the directions predetermined and record the numbers We assign to different groups. Blocking is usually used to create a balance in the number of specimens assigned to each of the groups studied, for example, in blocks of 4 that have two allocations to the intervention group and two allocations to the control group Is taken, Blinding description: Given the fact that the treatments are prescribed as unprinted tubes, also the appearance of both ointments is similar in both control and intervention groups, the patient will not be informed about her/his assignment to the control or intervention group. Forasmuch as groups will be marked by letters A and B; and patient assignment to either A or B groups will be done using block randomization, therefore, the treating and wound assessor physician will not be informed of the patient's group assignment when examining the wound using a checklist. This will reduce the observation bias (data collection) which arises from mental presupposition. The second principal researcher will also be unaware of the grouping details. Finally, the statistician will statistically analyze the data without knowing the treatment assigned to group A or B. The First Principal researcher is not blinded and can reopen the codes and be informed about the received treatments of each patient (if necessary or and at the end of the study). 3 Diabetic Foot Ulcer. Intervention 1: Intervention group: Dermaheal Ointment In the form of ready-to-use tubes without printing. The wound and surrounding tissues will be cleansed with saline solution and dried with sterile gauze. Then, the dermaheal ointment will be applied to the wound using an abaisse-langue and, fixed by the anti-allergic adhesive & a four-layer sterile dry gauze. Changing the dressing and applying the ointment should be done once a day for 4 weeks. Darmaheal ointment is a dressing based on herbal and natural products including Arnebia euchroma, thymes, Maticaria chamomilla L., Curcuma longa, wax, honey, and olive oil, which is produced by Darudarman Salafchegan Knowledge-Based Co. Intervention 2: Placebo group In the form of ready-to-use tubes without printing. The wound and surrounding tissues will be cleansed with saline solution and dried with sterile gauze. Then, the placebo dressing will be applied to the wound using an abaisse-langue and, fixed by the anti-allergic adhesive & a four-layer sterile dry gauze. Changing the dressing and applying the ointment should be done once a day for 4 weeks. Placebo dressing contains the inert substance Eucerin, which is produced by Darudarman Salafchegan Knowledge-Based Co. No - There is not a plan to make this available Justification or reason for not sharing IPD is ethical
public Mohammad Reza Amini
Dr. Shariati Hospital 5th floor
Tehran Iran (Islamic Republic of) 1411413137 +98 21 8822 0037 mramini@tums.ac.ir Endocrinology and Metabolism Research Institute scientific Mohammad Reza Mohajeri Tehrani
Dr. shariati Hospital
Tehran Iran (Islamic Republic of) 1411413137 +98 21 8822 0037 mrmohajeri@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Wagner G 1&2 Diabetic Foot Ulcer Neuropathic and Neuroischemin Ulcer 0.7 ≤ ABI ≤ 1.2 18 years 80 years Both Patient Disagreement to Participate Use of Medications that can Interfere with Wound Healing such as Corticosteroids, Immunosuppressive agents, and Cytotoxic agents E11.4 Type 2 diabetes mellitus with neurological complications Treatment - Drugs Placebo Intervention group: Dermaheal Ointment In the form of ready-to-use tubes without printing. The wound and surrounding tissues will be cleansed with saline solution and dried with sterile gauze. Then, the dermaheal ointment will be applied to the wound using an abaisse-langue and, fixed by the anti-allergic adhesive & a four-layer sterile dry gauze. Changing the dressing and applying the ointment should be done once a day for 4 weeks. Darmaheal ointment is a dressing based on herbal and natural products including Arnebia euchroma, thymes, Maticaria chamomilla L., Curcuma longa, wax, honey, and olive oil, which is produced by Darudarman Salafchegan Knowledge-Based Co. Placebo group In the form of ready-to-use tubes without printing. The wound and surrounding tissues will be cleansed with saline solution and dried with sterile gauze. Then, the placebo dressing will be applied to the wound using an abaisse-langue and, fixed by the anti-allergic adhesive & a four-layer sterile dry gauze. Changing the dressing and applying the ointment should be done once a day for 4 weeks. Placebo dressing contains the inert substance Eucerin, which is produced by Darudarman Salafchegan Knowledge-Based Co. Ulcer Area. Timepoint: End of every week. Method of measurement: Images & and ruler. Wound Discharge. Timepoint: End of every week. Method of measurement: Color, odor and amount by wound healing checklist. Surrounding tissues. Timepoint: End of every week. Method of measurement: Color, hotness, edema and sense by wound healing checklist. ABI. Timepoint: End of treatment. Method of measurement: ABI measurement Device. FBS. Timepoint: End of treatment. Method of measurement: Glucometer. Pain severity. Timepoint: End of every week. Method of measurement: Visual pain scale. Darudarman Salafchegan Co. (Knowledge-based) Approved 2020-09-23 Institutional Research committee Endocrine & Metabolism Research Institute - Tehran University of Me NO 10, Jalal-AL-Ahmad St., Chmaran HWY., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)