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IRCT20190810044500N20 IRCT 2021-08-22 Yazd University of Medical Sciences The effect of topical insulin and liothyronine on the healing of foot ulcer The effect of topical insulin and liothyronine on the healing of foot ulcer in patients with type 2 diabetes 2021-09-06 anticipated 78 Complete https://irct.ir/trial/46886 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 78 patients are randomly allocated into three treatment groups (A, B, and C). Block randomization method will be used for random allocation. Twelve blocks of six are considered. The generated permutations include the letters A, B, and C, which are repeated twice (for example, ABCABC) in each permutation. These permutations are generated using Random allocation software version 1. For this purpose, the generated list by the software is from 1 to 78, which are arranged in 12 blocks of six in order. To run this software output, we give the first qualified person number 1 and the last person will receive number 78. To consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study. In addition, in the software output, both numbers 1 to 78 and the permutations of the letters A, B, and C can be seen, Blinding description: After the products have been prepared, the first Executor, the treating physician, and the researcher monitoring the condition of the wounds will not be aware of any of the groupings performed. In this way, after preparing the products, liothyronine cream (150 mg liothyronine powder in 100 gr cold cream) or liothyronine/insulin cream (0.5 ml regular insulin in 99 gr liothyronine cream), these prepared creams and alpha cream (routine care), which all look the same, are placed in similar boxes. Then we ask another person to identify them with the codes A or B or C. 3 Diabetic foot ulcer. Intervention 1: Intervention group: Patients use topical liothyronine 0.75% cream twice a day for 12 weeks. Intervention 2: Intervention group: Patients use a combination topical cream of liothyronine 0.75% and insulin 0.5% twice a day for 12 weeks. Intervention 3: Control group: Patients use Alfa cream (routine care) twice a day. 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 further information.
public Fateme pasande
Professor Hesabi Boulevard-Yazd-Iran
yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 Pasandeelham73@gmail.com Yazd University of Medical Sciences scientific Fateme saghafi
Professor Hesabi Boulevard-yazd-Iran
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 saghafi.fa@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients over the age of 18 with a history of type 2 diabetes and hemoglobin A1C less than 10% Adequate literacy to fill the consent form, comprehension study Diabetic foot ulcer 18 years no limit Both Gangrene of the foot Osteomyelitis Severe sepsis History of alcohol consumption or substance abuse History of chronic diseases such as cancers or congestive heart failure, ESRD, liver failure Concomitant use of drugs that can adversely affect the wound healing process: glucocorticoids, immunosuppressive drugs, cytotoxic drugs Failure to sign a written consent Pregnant and lactating women Patients taking atrovastatin Patients with a history of steroid, cytotoxic or immunosuppressive drugs E11.621 Type 2 diabetes mellitus with foot ulcer Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Patients use topical liothyronine 0.75% cream twice a day for 12 weeks. Intervention group: Patients use a combination topical cream of liothyronine 0.75% and insulin 0.5% twice a day for 12 weeks. Control group: Patients use Alfa cream (routine care) twice a day. Percentage of wound closures 1 to 4 per week. Timepoint: Screening phase (7 days perior to drug administration in terms of entery criteria), treatment (day zero to 4 weeks), and follow-up phase (2 and 3 months). Method of measurement: REEDA score (3-0). Re-epithelialization. Timepoint: Screening phase (7 days perior to drug administration in terms of entery criteria), treatment (day zero to 4 weeks), and follow-up phase (2 and 3 months). Method of measurement: REEDA score (3-0). The severity of the pain. Timepoint: Examination from 7 days before prescribing the drug in terms of entry criteria, treatment (day zero to 4 weeks), and phase follow-up (2 and 3 months). Method of measurement: Basal Visual analogue Scale (VAS) criterion. Occurrence of side effects. Timepoint: At the end of the study. Method of measurement: Based on Morisky medication adherence scale. Yazd University of Medical Sciences Approved 2019-11-03 Ethics Committee of the Faculty of Medicine - Shahid Sadoughi University of Medical Sciences, Yazd Gomnam shohada boulevard,shahid sadoughi university of medical sciences Yazd Yazd Iran (Islamic Republic of)