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IRCT20080904001199N2 IRCT 2018-04-07 Endocrinology and Metabolism Research Institute Effect of cold plasma on diabetic foot ulcers پلاسمای سرد و زخم پای دیابتی Evaluation of the effectiveness of cold plasma radiation in the treatment of infected wounds diabetic foot and molecular mechanisms related 2017-04-04 anticipated 40 Complete https://irct.ir/trial/412 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, 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: Doctors and nurses, as well as the patient, are unaware of the grouping, and the only expert on plasma radiation is aware of this. Patients do not see the ulcer during plasma radiation. N/A Diabetic Foot Ulcer. Intervention 1: In this study, a cold jet plasma rifle machine will be used as a source of helium gas jet plasma. The plasma is created in 1 day intervals and each time for 5 minutes on the wound will be directly exposed. Intervention 2: Control group: In this group only standard wound care treatments such as debridement, dressing, antibiotic administration, and patient education, and no plasma radiation, will be used. 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 Endocrine Research Center Iran (Islamic Republic of) Diabetic patient with infected ulcer DFU grade 2 Neuropathic and Neuroischemin Ulcer ABI>0.8 , ABI<1.3 18 years 70 years Both Not patient compliance Ischemic ulcers Pregnancy cancer Dementia age< 18 Immunosuppressive therapy Gangrene Ulcer E11.4 Type 2 diabetes mellitus with neurological complications Treatment - Other Treatment - Other In this study, a cold jet plasma rifle machine will be used as a source of helium gas jet plasma. The plasma is created in 1 day intervals and each time for 5 minutes on the wound will be directly exposed. Control group: In this group only standard wound care treatments such as debridement, dressing, antibiotic administration, and patient education, and no plasma radiation, will be used. Area of ulcer. Timepoint: After selecting a patient for up to 3 weeks in each visit (one day in between), the size of the patient's wound is measured. Method of measurement: take a photo with ruler and analysis it. Microbial colony count. Timepoint: Up to 3 weeks after the patient's choice, once a week, a microbial culture of the wound secretions is performed. Method of measurement: with standard method swap. Cytokines and growth factors. Timepoint: at the first and end of third week. Method of measurement: 128/5000Samples from ulcerous secretions are taken with pasteurized sterile pipettes and then by ELISA, cytokines and growth factors are measured. Side effects of cold plasma radiation on the patient. Timepoint: During and after radiation of the plasma. Method of measurement: Ask the patient about possible symptoms and see the wound's position. Plasma physics research Center Endocrinology and Metabolism Research Institute Plasma physics research Center Approved 2016-03-02 Endocrinology and Metabolism Research Institute Dr. Shariati Hospital , 5th floor Tehran Tehran Iran (Islamic Republic of)