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IRCT20181105041563N3 IRCT 2018-12-18 Vice chancellor for research, Kermanshah University of Medical Sciences Comparative study on the effect of ozone therapy, honey dressing and combination of ozone and honey dressing on healing of diabetic foot ulcer Comparative study on the effect of ozone therapy, honey dressing and combination of ozone and honey dressing on healing of diabetic foot ulcer 2019-02-04 anticipated 140 Complete https://irct.ir/trial/35586 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Qualified samples were entered into the study by accessible method and randomly divided into intervention groups (Honey, Ozone and Honey-ozone) and control. Blocks were done as follows: To dressing groups with Honey, Ozone and Honey-ozone was assigned A ، B and C codes respectively, and the control group received D code. The study blocks were ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, and the ABCD block was selected as the first block. Patients were assigned to Honey,ozone ,Honey-ozone, and control groups, respectively, and this method continued until the samples were completed. 2-3 Diabetic foot ulcer. Intervention 1: Intervention group: Group 1: Wound, dressed daily, up to 8 weeks, with 405 honey. The brand of this dress is Mede Honey, produced by the Austrian Hartmann Company, wound healing by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study. Intervention 2: Intervention group: Group Two: Ozone therapy will be performed in eight weeks (16 times) with a Mead device, produced by Germany. Wound examination by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after Start treatment and at the end of the study. Intervention 3: Intervention group: Group 3: In addition to ozone therapy, honey dressing will also be done for 8 weeks. The wound examination is performed by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study. Intervention 4: Group 4: In the control group, only routine treatments will be performed. Includes daily washing, debridement, gas dressing and antibiotic therapy (based on prescribing physician). The wound examination is performed by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no specific program for publishing this project currently .
public Somayeh Mahdavikian
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6715986479 +98 83 3816 2560 Somayeh.Mahdavikian@kums.ac.ir Kermanshah School of Nursing and Midwifery scientific Somayeh Mahdavikian
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6715986479 +98 83 3816 2560 Somayeh.Mahdavikian@kums.ac.ir Kermanshah School of Nursing and Midwifery Iran (Islamic Republic of) Physician and patient satisfaction Age over 18 Do not use corticosteroid during the past month Do not use immunosuppressive drugs Lack of osteomyelitis Lack of smoking Insensitivity to honey and ozone therapy 18 years no limit Both Unwillingness to co-operate with a patient or physician Severe infection (Grade 4 system of the podium) Prescription Drugs Suppressing the Immune System and Corticosteroids Amputation Death E10-E14 Diabetes mellitus Treatment - Other Treatment - Other Treatment - Other Other Intervention group: Group 1: Wound, dressed daily, up to 8 weeks, with 405 honey. The brand of this dress is Mede Honey, produced by the Austrian Hartmann Company, wound healing by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study. Intervention group: Group Two: Ozone therapy will be performed in eight weeks (16 times) with a Mead device, produced by Germany. Wound examination by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after Start treatment and at the end of the study. Intervention group: Group 3: In addition to ozone therapy, honey dressing will also be done for 8 weeks. The wound examination is performed by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study. Group 4: In the control group, only routine treatments will be performed. Includes daily washing, debridement, gas dressing and antibiotic therapy (based on prescribing physician). The wound examination is performed by Beta Johnson, Padis and Wagner systems, one week after starting treatment, two weeks after starting treatment and at the end of the study. Healing of diabetic foot ulcer. Timepoint: One week after starting treatment, two weeks after starting treatment and at the end of the study. Method of measurement: Wagner ,pedis and beta johnson scale‬‏. Vice chancellor for research, Kermanshah University of Medical Sciences Approved 2018-08-14 Ethics committee of Kermanshah University of Medical Sciences Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)