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IRCT20200830048555N1 IRCT 2021-05-02 Tehran University of Medical Sciences Effect of comprehensive care program on the rate of wound healing in Diabetic Foot Patients Assessment of effect of comprehensive care program on the rate of wound healing in Diabetic Foot Patients treated with ozontherapy 2020-11-21 anticipated 41 Complete https://irct.ir/trial/50790 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients who meet the inclusion criteria enter the study in an accessible manner, The allocation method according to the table of random numbers with 4 permutations will be used. It will be determined that the intervention group with A and the control group with B and according to the patterns obtained from the table of random numbers, sampling will continue until the number of samples reaches the quorum in each group, Blinding description: Physician and clinical care provider Physicians and clinicians do not know which patient group is participating in the comprehensive training program Data Analyzer The obtained data is provided to the statistical analyst through the code of groups one and two. N/A Diabetic foot ulcers in ozone therapy. Intervention 1: Intervention group: In the intervention group, a comprehensive care plan for patients is started from the very beginning, and the necessary instructions are given to the patient individually, and a checklist is given in order for the patient to pay attention to the issues that need to be addressed.The patient should record information in it daily so that the level of comprehensive care plan can be checked. Twice a week, each patient will be contacted at a specific time agreed upon by the patient to answer the patient's questions and follow up on a comprehensive care plan. Intervention 2: Control group: without intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of participants' information
public Zahra Rooddehghan
Nosrat st.
Tehran Iran (Islamic Republic of) 141973317 0098216927171 Zrooddehghan@yahoo.com Tehran University of Medical Sciences scientific Zahra Rooddehghan
Nosrat st.
Tehran Iran (Islamic Republic of) 141973317 +98 21 6692 7171 Zrooddehghan@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) 18 to 65 years With type one or two diabetes Having grade 3 diabetic foot according to Wegener criteria No pregnancy Not having hyperthyroidism Absence of gangrene in the whole ankle No active osteomyelitis Complete the consent form Prescribe an ozone bag method for ozone therapy There is a wound on one of the legs 18 years 65 years Both Reluctance to continue research Transformation and treatment model in a more complex way The doctor decides to amputate E08 Diabetes mellitus due to underlying condition Rehabilitation N/A Intervention group: In the intervention group, a comprehensive care plan for patients is started from the very beginning, and the necessary instructions are given to the patient individually, and a checklist is given in order for the patient to pay attention to the issues that need to be addressed.The patient should record information in it daily so that the level of comprehensive care plan can be checked. Twice a week, each patient will be contacted at a specific time agreed upon by the patient to answer the patient's questions and follow up on a comprehensive care plan Control group: without intervention Size of diabetic foot ulcers according to Wegener scale. Timepoint: The first day of the examination and re-visit each time. Method of measurement: Take a photo of the wound at a distance of 30 cm while there is a measuring ruler & Wound depth with sterile applicator. Characteristics of diabetic foot ulcers according to Wegener scale. Timepoint: The first day of the examination and re-visit each time. Method of measurement: Wound characteristic with checklist. Tehran University of Medical Sciences Approved 2020-10-18 Ethics Committee in Research School of Nursing and Midwifery and School of Rehabilitation School of Nursing Midwifery,Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)