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General information
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either selenium supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either omega-3 supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either seleniumomega-3 supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
Protocol summary
Study aim
The aim of this study is to determine the effects of omega-3 supplementation on metabolic profiles in patients with diabetic foot.
Sixty patients with diabetic foot of eligible and referred to Infectious Clinic affiliated to Kashan University of Medical Sciences, Kashan, 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. Exclusion criteria is as follows: grade 3 DFU with abscess formation and osteomyelitis, subjects with significant arterial disease, major deformities e.g. Charcot's neuroarthropathy, pregnant and breastfed patients, taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids and change in consuming medications throughout the study.
Intervention groups
Patients will be assigned to receive either omega-3 supplements (intervention group: n=30) and placebo (control group: n=30).
Main outcome variables
Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201604025623N72
Registration date:2016-04-15, 1395/01/27
Registration timing:registered_while_recruiting
Last update:2019-09-22, 1398/06/31
Update count:2
Registration date
2016-04-15, 1395/01/27
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
Kashan University of Medical Sciences
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of omega-3 supplementation compared with the placebo on 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;
Aged 40 to 85 years
Exclusion criteria:
Grade 3 DFU with abscess formation and osteomyelitis
Subjects with significant arterial disease
Major deformities e.g. Charcot's neuroarthropathy
Pregnant and breastfed patients
Taking 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 omega-3 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 infectious clinic affiliated to Kashan University of Medical Sciences, 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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
IR.Kaums.REC.1394.173
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
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Glutathione
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
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
10
Description
HbA1c
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Biochemical kit
11
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
12
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention