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IRCT20080904001199N7 IRCT 2023-04-30 Tehran University of Medical Sciences Investigating the effectiveness of Alovera spray on diabetic foot ulcers Investigating the effectiveness of Alovera spray on diabetic foot ulcers 2023-05-22 anticipated 180 Complete https://irct.ir/trial/65035 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients referred to the diabetic foot ulcer clinic after selection based on inclusion and exclusion criteria are divided into three groups control, intervention 1, and intervention 2 using the Block Randomization method and blocks of 6. Using the study randomization available at https://www.sealedenvelope.com/ we will create sequences and blocks of 6 for randomization. Sealed Envelope Ltd. 2022. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 12 Dec 2022], Blinding description: In this study, three methods will be used to wash and disinfect the wound surface. After a general explanation to the patients about the method and type of treatment in this plan, the patients will be randomly assigned to treatment groups based on blocks by the principal researcher. The doctor and nurse have no role in choosing the treatment group, but they know which patients are in the intervention group and which are in the control groups. All three groups are given unlabeled sprays. Neither patients nor their families are aware of what type of spray they are using. The results of the study and grouping of patients are recorded as a code, so the data analyst is also unaware of the type of group therapy. 3 Diabetic Foot Ulcers. Intervention 1: Control group: In these patients, standard treatment (washing with normal saline, debridement and dressing) will be performed. Wound assessment will be done for patients during 5 sessions as weekly visits using the Triangle Wound Assessment tool. In every weekly visit, while washing the wound with normal saline solution and performing sharp debridement, the wound surface is covered with a suitable dressing. Meanwhile, the patient will use normal saline solution every other day during the week when changing the dressing (3 times). In each visit, the wound surface is also measured and recorded. Microbial culture will be done at the beginning of the intervention, the second week and the fifth week. The duration of the intervention is 5 weeks. Intervention 2: Intervention group 1: in these patients, in addition to the standard wound treatment (washing with normal saline, debridement and dressing), the surface of the wound will be disinfected using Silvocept spray with the main composition of silver (Chitotech company). Wound assessment is performed for patients during 5 sessions as a weekly visit using Triangle Wound Assessment tool. At each visit after sharp debridement, the surface of the wound is covered with gauze impregnated with Silvocept for 3-4 minutes and finally the surface of the wound is closed with a suitable dressing. In addition, the patient will use the spray in the same way during the week (3 times) when changing the dressing. At each visit, the wound surface is also measured and recorded. Microbial culture will be done before and after using the spray at the beginning of the intervention, the second week and the fifth week. The duration of the intervention is 5 weeks. Intervention 3: Intervention group 2: in these patients, in addition to the standard wound treatment (washing with normal saline, debridement and dressing), the surface of the wound will be disinfected using ALOVERA spray (Negin Daro Azerbaijan). Wound assessment is performed for patients during 5 sessions as a weekly visit using Triangle Wound Assessment tool. At each visit after debridement, the wound surface is covered with gauze soaked in ALOVERA for 3-4 minutes and finally the wound surface is closed with a suitable dressing. In addition, the patient will use the spray in the same way during the week (3 times) when changing the dressing. At each visit, the wound surface is also measured and recorded. Microbial culture will be done before and after using the spray at the beginning of the intervention, the second week and the fifth week. The duration of the intervention is 5 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical considerations
public Dr. Mohammad Reza Amini
Endocrinology Research Institute, 5th floor, Dr. Shariati Hospital, North Kargar St., Enghelab Square, Tehran
Tehran Iran (Islamic Republic of) 1411413137 +98 21 8822 0037 mramini@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Mohammad Reza Mohajeri Tehrani
Endocrinology Research Institute, 5th floor, Dr. Shariati Hospital, North Kargar St., Enghelab Square, Tehran
Tehran Iran (Islamic Republic of) 1411413137 +98 21 8822 0037 mrmohajeri@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with diabetic neuropathic and neuroischemic foot ulcers PEDIS Grade 1&2 Diabetic Foot Ulcer Wagner Grade 1, 2 and 3 Diabetic Foot Ulcer no limit no limit Both Getting infected with Covid-19 E11.4 Type 2 diabetes mellitus with neurological complications Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: In these patients, standard treatment (washing with normal saline, debridement and dressing) will be performed. Wound assessment will be done for patients during 5 sessions as weekly visits using the Triangle Wound Assessment tool. In every weekly visit, while washing the wound with normal saline solution and performing sharp debridement, the wound surface is covered with a suitable dressing. Meanwhile, the patient will use normal saline solution every other day during the week when changing the dressing (3 times). In each visit, the wound surface is also measured and recorded. Microbial culture will be done at the beginning of the intervention, the second week and the fifth week. The duration of the intervention is 5 weeks. Intervention group 1: in these patients, in addition to the standard wound treatment (washing with normal saline, debridement and dressing), the surface of the wound will be disinfected using Silvocept spray with the main composition of silver (Chitotech company). Wound assessment is performed for patients during 5 sessions as a weekly visit using Triangle Wound Assessment tool. At each visit after sharp debridement, the surface of the wound is covered with gauze impregnated with Silvocept for 3-4 minutes and finally the surface of the wound is closed with a suitable dressing. In addition, the patient will use the spray in the same way during the week (3 times) when changing the dressing. At each visit, the wound surface is also measured and recorded. Microbial culture will be done before and after using the spray at the beginning of the intervention, the second week and the fifth week. The duration of the intervention is 5 weeks. Intervention group 2: in these patients, in addition to the standard wound treatment (washing with normal saline, debridement and dressing), the surface of the wound will be disinfected using ALOVERA spray (Negin Daro Azerbaijan). Wound assessment is performed for patients during 5 sessions as a weekly visit using Triangle Wound Assessment tool. At each visit after debridement, the wound surface is covered with gauze soaked in ALOVERA for 3-4 minutes and finally the wound surface is closed with a suitable dressing. In addition, the patient will use the spray in the same way during the week (3 times) when changing the dressing. At each visit, the wound surface is also measured and recorded. Microbial culture will be done before and after using the spray at the beginning of the intervention, the second week and the fifth week. The duration of the intervention is 5 weeks. Wound area. Timepoint: Before the intervention - the first week after the intervention - the second week after the intervention - the third week after the intervention - the fourth week after the intervention - the fifth week after the intervention. Method of measurement: Using a ruler and ImageJ software. The bacterial load on the wound surface. Timepoint: Before the intervention - the second week after the intervention - the fifth week after the intervention. Method of measurement: Microbial culture will be done using swap and agar medium. Negin Daro Azerbaijan CO Tehran University of Medical Sciences Negin Daro Azerbaijan CO Approved 2023-03-01 Ethics Committee of the Endocrinology and Metabolism Research Institute, Tehran University of Medica Endocrinology Research Institute, 5th floor, Dr. Shariati Hospital, North Kargar St., Enghelab Square, Tehran Tehran Tehran Iran (Islamic Republic of)