Protocol summary
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Study aim
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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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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Patients with diabetic foot and aged 40 to 85 years will be included in this study.
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Intervention groups
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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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Main outcome variables
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Mean ulcer area and metabolic profiles
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2016-03-22, 1395/01/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Babol University of Medical Sciences
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Expected recruitment start date
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2016-02-15, 1394/11/26
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Expected recruitment end date
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2016-03-15, 1394/12/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of supplementation in treatment of patients with diabetic foot
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 85 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-02-14, 1394/11/25
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Ethics committee reference number
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IR.MUBABOL.REC.1394.308
Health conditions studied
1
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Description of health condition studied
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Diabetic foot
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ICD-10 code
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E11 and E1
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ICD-10 code description
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Non-insulin-dependent diabetes mellitus and with peripheral circulatory complications
Primary outcomes
1
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
2
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Description
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Healing of diabetic foot ulcer
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
Secondary outcomes
1
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
5
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Description
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Total antioxidant
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
7
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Description
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LDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
8
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Fasting plasma glucose
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
10
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Description
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HbA1c
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Biochemical kit
11
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
12
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
13
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Description
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Erythrocyte sedimentation rate
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Westergren method
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available