]>
IRCT20100107003014N24 IRCT 2021-06-18 Vice chancellor for research and technology, Mazandaran University of Medical Sciences Evaluation the effects of Atorvastatin on diabetic foot Evaluation of Atorvastatin Gel on improvement of diabetic foot ulcer : A Prospective, double-Blind, Randomized,clinical Trial 2019-11-11 anticipated 60 Complete https://irct.ir/trial/38122 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be treated with atorvastatin gel and placebo using the blocking method. The generation of random numbers is done with Random allocation software, and 60 samples will be assigned in 15 blocks of 4. All products used in the study are completely identical in terms of appearance and packaging, and their content will be characterized by a four-digit code, Blinding description: The gel containing the active ingredient and placebo gel is in the same package with the same color and appearance. The gel tubes were coded by the first performer (data analyzer).Therefore, patients, clinical colleagues, and working students do not know any of the codes' meanings. The tubes are randomly selected and used by patients. 3 Diabetic foot ulcer. Intervention 1: Control group: Patients in this group (selected randomly and double blindly) will use a placebo gel. Gel formulation without any drugs (formulation without active ingredient, and contains propylene glycol, ethanol, glycerin and carbomer obtained from Dr. Mojallali Industrial Chemical Complex Co.) ,once every 3 days, for one month. Intervention 2: Intervention group: Patients in this group (selected randomly and double blindly) will use an atorvastatin 2% gel .Gel formulation containing the drug(active ingredient: atorvastatin 2% powder obtained from Tehran Chemie Pharmaceutical CO .In addition to the active ingredient, the formulation contains propylene glycol, ethanol, glycerin and carbomer) ,once every 3 days, for one month. 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 not any more information
public Parham Salehi
Faculty of pharmacy, Payambar Azam university complex, Mazandaran University of Medical Sciences, Km 18 Khazar abad road, Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 1354 3083 parhamsalehi053@gmail.com Mazandaran University of Medical Sciences scientific Dr. Shahram Ala
Faculty of pharmacy, Payambar Azam university complex, Mazandaran University of Medical Sciences, Km 18 Khazar abad road, Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 1354 3083 sh204ala@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Having Diabetic Wounds Grade 1 and 2 Based on Wagner Ratings Having a single sore in the legs or the ends of the fingers (and the sole of the leg or heel)  Which has lasted at least 4 weeks 18 years no limit Both Having diseases that  causing wound healing problems Like liver and kidney failure, heart failure, various cancers, vasculitis Taking alcohol and cigarettes or any drugs The presence of infectious ulcers requiring amputations. E11.621 Type 2 diabetes mellitus with foot ulcer Placebo Treatment - Drugs Control group: Patients in this group (selected randomly and double blindly) will use a placebo gel. Gel formulation without any drugs (formulation without active ingredient, and contains propylene glycol, ethanol, glycerin and carbomer obtained from Dr. Mojallali Industrial Chemical Complex Co.) ,once every 3 days, for one month Intervention group: Patients in this group (selected randomly and double blindly) will use an atorvastatin 2% gel .Gel formulation containing the drug(active ingredient: atorvastatin 2% powder obtained from Tehran Chemie Pharmaceutical CO .In addition to the active ingredient, the formulation contains propylene glycol, ethanol, glycerin and carbomer) ,once every 3 days, for one month Changing the degree of ulcer. Timepoint: Wound grade measurement at the beginning of the study (before intervention)  And 7, 14 and 21 days After starting to use a drug gel. Method of measurement: Measuring the size of the wound, the amount of erythema, the amount of pain (VAS criteria) and Irritation. Permanent pain. Timepoint: Measuring the amount of pain at the beginning of the study, the first week, the second, third ,and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Visual Analogue Scale. Wound Scope. Timepoint: Measuring the wound scope at the beginning of the study, the first week, the second, third ,and fourth weeks after the start of the study, is evaluated and recorded. Method of measurement: Observation with measuring instruments. Side effect during treatment. Timepoint: The type of side effect measured during treatment at the first, second, third and fourth week after the start of treatment. Method of measurement: observation and according to questionnaire. Vice chancellor for research and technology, Mazandaran University of Medical Sciences Approved 2020-01-01 Ethics committee of Mazandaran University of Medical Sciences Ethics department of Mazandaran University of Medical Sciences, Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)