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IRCT2017090533941N21 IRCT 2017-11-16 Kashan University of Medical Sciences Effect of combined magnesium and vitamin E supplementation in treatment of diabetic foot ulcer Clinical trial of the effect of combined magnesium and vitamin E supplementation compared with the placebo on metabolic profiles in patients with diabetic foot ulcer 2017-10-20 anticipated 60 Complete https://irct.ir/trial/26063 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either combined magnesium and vitamin E supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti clinic, Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 2 Diabetic foot ulcer. Intervention 1: Intervention group: 250 mg magnesium (21st Century, Arizona, USA) and 400 IU vitamin E (Zahravi, Tabriz, Iran) daily for 12 weeks orally. Intervention 2: Control group: Placebo capsule (Barij Essence, Kashan, Iran), daily for 12 weeks orally. 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 Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with grade 3 diabetic foot ulcer Aged 40 to 85 40 years 85 years Both Pregnant and breastfed patients Participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months Taking anti-inflammatory agents Change in consuming medications throughout the study Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma E14.5 Non-insulin-dependent diabetes mellitus and with peripheral circulatory complications Treatment - Drugs Treatment - Drugs Intervention group: 250 mg magnesium (21st Century, Arizona, USA) and 400 IU vitamin E (Zahravi, Tabriz, Iran) daily for 12 weeks orally. Control group: Placebo capsule (Barij Essence, Kashan, Iran), daily for 12 weeks orally. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Healing of diabetic foot ulcer. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm). Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HbA1c. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Biochemical kit. Magnesium. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Kashan University of Medical Sciences Approved 2017-10-19 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)