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IRCT201603085623N68 IRCT 2016-03-22 Babol University of Medical Sciences Effect of supplementation in treatment of patients with diabetic foot Clinical trial of the effect of probiotic supplementation compared with the placebo on wound healing and metabolic profiles in patients with diabetic foot 2016-02-15 anticipated 60 Complete https://irct.ir/trial/6098 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 probiotic 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 Rouhani Hospital affiliated to Babol University of Medical Science, 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. Intervention 1: Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), Lactobacillus Fermentum (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally. Intervention 2: Control group: Placebo, 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 5562 0608 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 diabetic foot Ulcer Aged 40 to 85 years 40 years 85 years Both Grade 3 DFU with abscess formation and osteomyelitis History of diseases which influence the development of diabetic foot Ulcer including prior history of wounds Pregnant and breastfed patients Taking probiotic supplements and other forms of probiotics including probiotic yogurt, kefir and other fermented foods Taking prebiotic Antioxidant and/or anti-inflammatory supplements, such as vitamin E, vitamin C and omega-3 fatty acids Change in consuming medications throughout the study E11 and E1 Non-insulin-dependent diabetes mellitus and with peripheral circulatory complications Treatment - Drugs Treatment - Drugs Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), Lactobacillus Fermentum (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally. Control group: Placebo, daily, for 12 weeks orally. 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). 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-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. LDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. 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. Insulin. 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. Erythrocyte sedimentation rate. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Westergren method. Babol University of Medical Sciences Approved 2016-02-14 Ethics committee of Babol University of Medical Sciences Ganjafrooz Street, Babol Babol Mazandaran Iran (Islamic Republic of)