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Clinical trial of the effect of probiotic supplementation compared with the placebo on wound healing and metabolic profiles in patients with diabetic foot

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History
# Registration date Revision Id
2 2019-09-17, 1398/06/26 103940
1 2016-03-22, 1395/01/03 6098
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  • Protocol summary

    Objective: The aim of this study is to determine the effects of probiotic supplementation on metabolic profiles in patients with diabetic foot. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with diabetic foot and aged 35 to 75 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with diabetic foot of eligible and referred to Rouhani Clinic affiliated to Babol University of Medical Sciences, Babol, Iran in the study will be selected. Intervention: Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and end date of intervention: 12 weeks. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
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    هدف: هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است. طراحي انجام مطالعه: تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به زخم پای دیابتی در محدوده سنی 35 تا 75 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری از مطالعه خارج خواهند شد. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک روحانی وابسته به دانشگاه علوم پزشکی بابل، بابل، ایران در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران برای دریافت مکمل پروبیوتیک (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: پروفایل های متابولیک در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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    The aim of this study is to determine the effects of probiotic supplementation on wound healing and metabolic profiles in patients with diabetic foot.
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    هدف این مطالعه تعیین اثرات مکمل یاری پروبیوتیک بر بهبود زخم و پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است.
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    Parallel double-blind (both patients and researchers) randomized controlled clinical trial
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    تصادفي کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
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    60 patients with diabetic foot of eligible and referred to Rouhani Clinic affiliated to Babol University of Medical Sciences, Babol, Iran in the study will be selected.
    empty
    60 بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک روحانی وابسته به دانشگاه علوم پزشکی بابل، بابل، ایران در مطالعه انتخاب خواهند شد.
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    Patients with diabetic foot and aged 40 to 85 years will be included in this study.
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    بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال وارد مطالعه خواهند شد.
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    Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
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    بیماران برای دریافت مکمل پروبیوتیک (گروه مداخله:30=n) و پلاسبو (گروه کنترل: 30=n) تقسیم خواهند شد.
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    Mean ulcer area and metabolic profiles
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    میانگین مساحت زخم و پروفایل های متابولیک

  • General information

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    2016-02-14, 1394/11/25
    2016-02-15, 1394/11/26
    Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in 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
    کارآزمایی بالینی اثر مکمل یاری پروبیوتیک در مقایسه با پلاسبو بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی
    کارآزمایی بالینی اثر مکمل یاری پروبیوتیک در مقایسه با پلاسبو بر التیام زخم و پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی
    Patients with diabetic foot Ulcer
    Aged 40 to 85 years
    یماران مبتلا به زخم پای دیابتی؛
    سنین 40 تا 85 سال
    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
    زخم پای دیابتیک درجه سه با تشکیل آبسه و پوکی استخوان
    سابقه بیماری هایی که پیشرفت زخم پای دیابتی را تحت تاثیر قرار میدهد از جمله سابقه قبلی زخم
    بیماران باردار و شیرده
    مصرف مکمل های پروبیوتیک و اشکال دیگر پروبیوتیک ها از جمله ماست پروبیوتیک ، کفیر و سایر غذاهای تخمیر شده
    مصرف پره-بیوتیک
    مکمل های آنتی اکسیدانی و ضد التهابی مانند ویتامین E، ویتامین C و اسید چرب امگا 3
    تغییر در مصرف داروها در طول مطالعه
    Random assignment will be done by the use of computer-generated random numbers.
    تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    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.
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    در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل پروبیوتیک (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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    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.
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    تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در بیمارستان روحانی وابسته به دانشگاه علوم پزشکی بابل که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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  • Primary outcomes

    #1
    Questionnaire
    Calculation using HOMA formula
    پرسشنامه
    محاسبه با استفاده از فرمول HOMA
    #2
    Insulin
    Healing of diabetic foot ulcer
    انسولین
    بهبود زخم پای دیابتی
    Elisa kit
    Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
    کیت الایزا
    کاهش اندازه زخم نسبت به اندازه اصلی: طول زخم (سانتی متر) ، عرض زخم (سانتی متر) ، عمق زخم (سانتی متر)

  • Secondary outcomes

    #1
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    LDL-cholesterol
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    کلسترول LDL
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #2
    empty
    Malondialdehyde
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    مالون دی آلدئید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #3
    empty
    Fasting plasma glucose
    empty
    گلوکز پلاسمایی ناشتا
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #4
    empty
    HbA1c
    empty
    HbA1c
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Biochemical kit
    empty
    کیت بیوشیمیایی
    #5
    empty
    Insulin
    empty
    انسولین
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Elisa kit
    empty
    کیت الایزا
    #6
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    Nitric oxide
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    نیتریک اکساید
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    Spectrophotometry
    empty
    اسپکتروفتومتری
    #7
    empty
    Erythrocyte sedimentation rate
    empty
    سرعت رسوب گلبول قرمز
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
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    Westergren method
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    روش وسترگرین

  • Recruitment centers

    #1
    Name of recruitment center - English: Rouhani Clinic
    Name of recruitment center - Persian: کلینیک روحانی
    Full name of responsible person - English: Masomeh Bayani
    Full name of responsible person - Persian: معصومه بیانی
    Street address - English: Ganjafrooz Street, Babol
    Street address - Persian: بابل،خیابان گنج افروز
    City - English: Babol
    City - Persian: بابل
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Rouhani Clinic
    Name of recruitment center - Persian: کلینیک روحانی
    Full name of responsible person - English: Masomeh Bayani
    Full name of responsible person - Persian: معصومه بیانی
    Street address - English: Ganjafrooz Street, Babol
    Street address - Persian: بابل،خیابان گنج افروز
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone: +98 11 3223 8301
    Fax:
    Email: info@mubabol.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Babol University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی بابل
    Full name of responsible person - English: Ali Bijani
    Full name of responsible person - Persian: علی بیژنی
    Street address - English: Ganjafrooz Street, Babol
    Street address - Persian: بابل،خیابان گنج افروز
    City - English: Babol
    City - Persian: بابل
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ali Bijani
    Full name of responsible person - Persian: علی بیژنی
    Street address - English: Ganjafrooz Street, Babol
    Street address - Persian: بابل،خیابان گنج افروز
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: 4717647745
    Phone: +98 11 3219 0149
    Fax:
    Email: research@mubabol.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
    Vice chancellor for research, Babol University of Medical Sciences
    Babol University of Medical Sciences
    معاونت پژوهشی دانشگاه علوم پزشکی بابل
    دانشگاه علوم پزشکی بابل

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English:
    Full name of responsible person - Persian:
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work:
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available:
    Country:
    Postal code:
    Phone:
    Mobile:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: Nutritionist
    Position - Persian: متخصص تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5562 0608
    Mobile: 098 9133615446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکترای تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Kashan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکتری تغذیه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zatollah Asemi
    Full name of responsible person - Persian: ذات اله عاصمی
    Position - English: PhD of Nutrition
    Position - Persian: دکتری تغذیه
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 81151-87159
    Phone: +98 31 5546 3378
    Mobile: +98 913 361 5446
    Fax:
    Email: asemi_z@kaums.ac.ir
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Undecided - It is not yet known if there will be a plan to make this available
    empty
    هنوز تصمیم نگرفته‌ام - برنامه انتشار آن هنوز مشخص نیست

Protocol summary

Study aim
The aim of this study is to determine the effects of probiotic supplementation on wound healing and metabolic profiles in patients with diabetic foot.
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial
Settings and conduct
60 patients with diabetic foot of eligible and referred to Rouhani Clinic affiliated to Babol University of Medical Sciences, Babol, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients with diabetic foot and aged 40 to 85 years will be included in this study.
Intervention groups
Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
Main outcome variables
Mean ulcer area and metabolic profiles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201603085623N68
Registration date: 2016-03-22, 1395/01/03
Registration timing: retrospective

Last update: 2019-09-17, 1398/06/26
Update count: 1
Registration date
2016-03-22, 1395/01/03
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2016-02-15, 1394/11/26
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Clinical trial of the effect of probiotic supplementation compared with the placebo on wound healing and metabolic profiles in patients with diabetic foot
Public title
Effect of supplementation in treatment of patients with diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot Ulcer Aged 40 to 85 years
Exclusion criteria:
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
Age
From 40 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafrooz Street, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2016-02-14, 1394/11/25
Ethics committee reference number
IR.MUBABOL.REC.1394.308

Health conditions studied

1

Description of health condition studied
Diabetic foot
ICD-10 code
E11 and E1
ICD-10 code description
Non-insulin-dependent diabetes mellitus and with peripheral circulatory complications

Primary outcomes

1

Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula

2

Description
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)

Secondary outcomes

1

Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

2

Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

3

Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

5

Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

6

Description
hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

7

Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

8

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

9

Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

10

Description
HbA1c
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Biochemical kit

11

Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

12

Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

13

Description
Erythrocyte sedimentation rate
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Westergren method

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
Control group: Placebo, daily, for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rouhani Clinic
Full name of responsible person
Masomeh Bayani
Street address
Ganjafrooz Street, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3223 8301
Email
info@mubabol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Ganjafrooz Street, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0149
Email
research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
asemi_z@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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