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IRCT20200220046560N1 IRCT 2021-04-09 Oroumia University of Medical Sciences Evaluation of The efficacy of topical Melatonin on healing of diabetic foot Evaluation of The efficacy of topical Melatonin on healing of diabetic foot ulcers in a double blind placebo-controlled clinical trial 2021-04-01 anticipated 36 Complete https://irct.ir/trial/54495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be used in this study. The size of all blocks is equal and 5 blocks of 10 including 18 patients in the intervention group and 18 patients in the control group will be used.(with considering 20% drop out) To determine the random sequence of drug and placebo allocation within each block, the site https://studyrandomizer.com/ is used and the sequences (sequence within block) are received in the form of an Excel file from the site. The output file will be assigned to each person a four-part code consisting of a letter and three digits separated by commas. In order to conceal random allocation, the method of opaque sealed envelopes with random sequence will be used. thirty six envelopes with aluminum wrappers (in order to obscure the contents of the envelopes) will be prepared and each of the random sequences created on one card will be recorded and the cards will be placed in the envelopes respectively. In order to maintain a random sequence, the envelopes will be numbered in the same way on the outer surface, Blinding description: Both patients and researcher do not know about type of drug that receive ( melatonin or placebo) and are blinded. Placebo are prepared in same shape and color of melatonin topical Gel. Drug and placebo are coded in A and B groups with block randomization method. Then they are given to the researcher and patients. 2-3 diabetic foot. Intervention 1: Intervention group: Receive a topical form of melatonin (Razak Pharmaceutical Company) with standard regime(Blood sugar control, regular wound washing, pressure reduction on the wound, treatment with oral antibiotics if needed) and the instruction to use overnight rub into the wound for 8 weeks and the ultimate goal is to use one milligram of melatonin (0.2%) per square centimeter of wound. Intervention 2: Control group: Receive a topical form of placebo (Distilled water, carbomer, TEA) (school of pharmacy)with standard regime and the instruction to use overnight rub into the wound for 8 weeks. Yes - There is a plan to make this available What will be shared: average of age, sex, comorbidity, laboratory date When: article publish time To whom: scientific Conditions: 19 / 5000 Translation results Assess the accuracy of the study Where to obtain: Responsible for the project How to obtain: Must be notified to the project manager through the journal in which the article was submitted Comments:
public Ayda Esmaeili
Imam Khomeini Hospital, Ershad Ave., Urmia, I.R.IRAN
urmia Iran (Islamic Republic of) 571478334 +98 44 3346 9931 ph.a.esmaeili@gmail.com Oroumia University of Medical Sciences scientific Ayda Esmaeili
Imam Khomeini Hospital, Ershad Ave., Urmia, I.R.IRAN
ارومیه Iran (Islamic Republic of) 571478334 +98 44 3346 9931 ph.a.esmaeili@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients equal and more18 years old Grade 1 or 2 diabetic foot ulcers based on wagner Patients with HgbA1c<=10% Obtain informed consent The size of the wound is more than one cm2 Index affected by ankle> 0.4 or Color Doppler Ultrasound with no result of severe vascular involvement 18 years no limit Both Need to have injectable antibiotics Allergy to topical melatonin product Patients with uncontrolled epilepsy Pregnancy and lactation Any skin disorder leads to ulcer Causes of wounds other than diabetes such as trauma Wounds happened in less than 2 weeks Patients treated with chemotherapy or radiotherapy Use of drugs that interfere with wound healing, such as: corticosteroids at least the equivalent dose of 40 mg of prednisolone, mycophenolate, cyclosporine, tacrolimus, rituximab Patients with renal disease at stage 5(GFR<15 ml/min) or on dialysis E11.62 Type 2 diabetes mellitus with skin complications Treatment - Drugs Treatment - Drugs Intervention group: Receive a topical form of melatonin (Razak Pharmaceutical Company) with standard regime(Blood sugar control, regular wound washing, pressure reduction on the wound, treatment with oral antibiotics if needed) and the instruction to use overnight rub into the wound for 8 weeks and the ultimate goal is to use one milligram of melatonin (0.2%) per square centimeter of wound. Control group: Receive a topical form of placebo (Distilled water, carbomer, TEA) (school of pharmacy)with standard regime and the instruction to use overnight rub into the wound for 8 weeks. Wound area. Timepoint: At the baseline (before intervention) and at the fourth week , Eighth week of intervention. Method of measurement: Using photos and area measurements. Sleep quality. Timepoint: Start of study, eighth week. Method of measurement: sleep questionnaire(Pittsburgh Sleep Quality Index). Life quality. Timepoint: Start of study, eighth week. Method of measurement: Diabetic Foot Ulcer Scale(DFS). Oroumia University of Medical Sciences Approved 2021-01-20 The ethics committee of Urmia University of Medical Sciences Imam Khomeini Hospital, Ershad Ave., Urmia, I.R.IRAN Urmia West Azarbaijan Iran (Islamic Republic of)