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IRCT20080904001199N8 IRCT 2023-08-05 Nikan Teb Kimia Company Determining the effectiveness of Hyiodine comparison standard treatment on healing of Diabetic Foot Ulcer Evaluation of the effectiveness of Hyiodine comparison standard treatment on healing of Diabetic Foot Ulcer: a randomized single-blind controlled trial 2023-08-23 anticipated 96 Complete https://irct.ir/trial/71536 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Diabetic patients with foot ulcers are randomly divided into two groups "control, intervention" after examination and if they meet the criteria to enter the trial. The random block method with blocks of four will be used by using /www.sealedenvelope.com for random allocation. A numerical code is defined for the random sequence, and people receive the numerical code in the same order as they enter and are placed in the corresponding group according to the block, Blinding description: Except nurse who will dressing, the executive agents of the study and statistical analysis will not be informed about the code of the random sequence. In this study, the nurse (or doctor) measuring the size of the wound, the microbiology laboratory staff and the statistical analyzer are unaware of the allocation of patients to the study groups, but the patients cannot be blind due to the difference in the shape of the dressings. 3 Condition 1: Diabetic Foot Ulcers. Condition 2: Diabetic Foot Ulcers. Intervention 1: Control group: These patients will receive standard treatment including washing with normal saline, debridement and dressing. Every week, after performing sharp debridement and washing the wound with normal saline solution, the wound surface is appropriately dressed. In addition, the patient changes the dressing every 48 hours during the week (three times a week) using saline solution. At the beginning of the treatment and at the end of each week when the patient visits, the wound surface is measured and recorded. Microbial cultures are performed before the intervention, in the second week and in the fourth week after the intervention. The duration of the intervention is four weeks. Intervention 2: Intervention group: in these patients, in addition to the standard wound treatment (washing with normal saline, debridement and dressing), the wound surface will be disinfected using Hyiodine (Nikan Teb Kimia Company). At each visit after debridement, the wound surface is covered with gauze impregnated with Hyiodine and finally the wound surface is closed with a suitable dressing. Meanwhile, during the week, the patient will use Hyiodine solution every 48 hours (three times a week) when changing the dressing in the same way. At the beginning of the treatment and at the end of each week when the patient visits, the wound surface is measured and recorded. Microbial cultures are performed before the intervention, in the second week and in the fourth week after the intervention. The duration of the intervention is four 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 Patients with PEDIS Grade 1 and 2 Diabetic Foot Ulcer Patients with Wagner Grade 1 and 2 Diabetic Foot Ulcer Patient with the hemoglobin A1c less than and equal to 8.5 30 years 65 years Both Getting infected with Covid-19 have skin allergies have thyroid disease have coagulation disorders E10.621 E11.621 Type 1 diabetes mellitus with foot ulcer Type 2 diabetes mellitus with foot ulcer Treatment - Drugs Treatment - Drugs Control group: These patients will receive standard treatment including washing with normal saline, debridement and dressing. Every week, after performing sharp debridement and washing the wound with normal saline solution, the wound surface is appropriately dressed. In addition, the patient changes the dressing every 48 hours during the week (three times a week) using saline solution. At the beginning of the treatment and at the end of each week when the patient visits, the wound surface is measured and recorded. Microbial cultures are performed before the intervention, in the second week and in the fourth week after the intervention. The duration of the intervention is four weeks. Intervention group: in these patients, in addition to the standard wound treatment (washing with normal saline, debridement and dressing), the wound surface will be disinfected using Hyiodine (Nikan Teb Kimia Company). At each visit after debridement, the wound surface is covered with gauze impregnated with Hyiodine and finally the wound surface is closed with a suitable dressing. Meanwhile, during the week, the patient will use Hyiodine solution every 48 hours (three times a week) when changing the dressing in the same way. At the beginning of the treatment and at the end of each week when the patient visits, the wound surface is measured and recorded. Microbial cultures are performed before the intervention, in the second week and in the fourth week after the intervention. The duration of the intervention is four 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. Method of measurement: Using digital calipers and ImageJ software. After washing and debriding the wound to measure the surface of the wound, in addition to photography, a digital caliper is used to calculate the largest length and width of the wound. The depth of the wound is also measured and recorded using a probe. The bacterial load on the wound surface. Timepoint: Before the intervention - the second week after the intervention- the fourth week after the intervention. Method of measurement: Microbial culture will be done using swap and agar medium. Bacterial colonies are reported qualitatively and quantitatively. Side effects of treatment. Timepoint: throughout the intervention and the fifth week after the intervention. Method of measurement: There will be phone and in-person reviews. Registration is done in the case report form (CRF). Nikan Teb Kimia Company Approved 2023-07-15 Research Ethics Committees of Endocrine & Metabolism Research Institute - Tehran University of Medic Endocrinology Research Institute, 5th floor, Dr. Shariati Hospital, North Kargar St., Enghelab Square, Tehran Tehran Tehran Iran (Islamic Republic of)