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IRCT20181105041563N5 IRCT 2020-07-22 Kermanshah University of Medical Sciences A comparative analysis of the efficacy of phenytoin and Betadine on healing of diabetic foot ulcer A comparative analysis of the efficacy of phenytoin and Betadine on healing of diabetic foot ulcer 2020-08-22 anticipated 80 Complete https://irct.ir/trial/44950 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 intervention group (phenytoin-betadine) and control group(conventional wound dressing) . Blocks were done as follows: To intervention group was assigned A code , and the control group received B code. The study blocks were AB, and BA . the AB block was selected as the first block. Patients were assigned to intervention group (phenytoin-betadine) and control group (conventional wound dressing) , respectively, and this method continued until the samples were completed. 3 Diabetic foot ulcer. Intervention 1: Intervention group:Wound, washed daily, up to 8 weeks, with iodine 10% produced by Kimia Daroo then a phenytoin compound capsule produced by Caspian Tamin Pharmaceutical Company will poure into the wound so that it is covered 1mm.The wound examination is performed by Beta Johnson, Padis and Wagner systems, One, two, three, four, six, eight, ten, and twelve weeks after starting treatment and at the end of the study. Intervention 2: 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, two, three, four, six, eight, ten, and twelve weeks after starting treatment and at the end of the study. Yes - There is a plan to make this available What will be shared: Data on the main outcome of the study is available for sharing. When: Six months after the publication of the results in the form of the article To whom: Researchers working in academic institutions Conditions: Only to conduct similar studies in other populations. Where to obtain: somayeh mahdavikian with below email address: smahdavikia@gmail.com and phone number +98 83 3827 9394 How to obtain: A week after receiving an email or phone call, it will take action. Comments:
public Somayeh Mahdavikian
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714634698 +98 83 3816 2560 Somayeh.Mahdavikian@kums.ac.ir Kermanshah University of Medical Sciences scientific Somayeh Mahdavikian
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714634698 +98 83 3816 2560 Somayeh.Mahdavikian@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Physician and patient satisfaction Patient alertness (GCS = 15) Age over 18 do not allergic to to iodine and phenytoin No pregnancy Lack of hepatic impairment and renal failure (creatinine level below 2), cancer and osteomyelitis Do not use immunosuppressive and corticosteroid during the last month No smoking Controlled blood sugar Grade I and II foot ulcers according to Meggit-Wagner 18 years no limit Both Unwillingness to co-operate with a patient or physician Grade III, IV, V foot ulcers according to Meggit-Wagner Amputation Death L97 Ulcer of lower limb, not elsewhere classified Treatment - Other Treatment - Other Intervention group:Wound, washed daily, up to 8 weeks, with iodine 10% produced by Kimia Daroo then a phenytoin compound capsule produced by Caspian Tamin Pharmaceutical Company will poure into the wound so that it is covered 1mm.The wound examination is performed by Beta Johnson, Padis and Wagner systems, One, two, three, four, six, eight, ten, and twelve weeks after starting treatment and at the end of the study 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, two, three, four, six, eight, ten, and twelve weeks after starting treatment and at the end of the study Length and width of diabetic foot ulcer. Timepoint: One, two, three, four, six, eight, ten, and twelve weeks after starting treatment and at the end of the study. Method of measurement: ruler. Grade of diabetic foot ulcer. Timepoint: One, two, three, four, six, eight, ten, and twelve weeks after starting treatment and at the end of the study. Method of measurement: Wagner ,Pedis and Beta johnson scale. Infection of diabetic foot ulcer. Timepoint: One, two, three, four, six, eight, ten, and twelve weeks after starting treatment and at the end of the study. Method of measurement: Pedis scale. Kermanshah University of Medical Sciences Approved 2020-07-08 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)