Protocol summary
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Study aim
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The aim of this study is to determine the effects of omega-3 supplementation on metabolic profiles in patients with diabetic foot.
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Design
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Randomized controlled clinical trial, Parallel, double-blind, 60 patients, phase 2
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Settings and conduct
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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.
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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. 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.
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Intervention groups
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Patients will be assigned to receive either omega-3 supplements (intervention group: n=30) and placebo (control group: n=30).
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Main outcome variables
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Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area
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:
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
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Registration date
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2016-04-15, 1395/01/27
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2016-03-10, 1394/12/20
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Expected recruitment end date
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2016-04-20, 1395/02/01
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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 omega-3 supplementation compared with the placebo on 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;
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
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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 omega-3 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 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.
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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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2016-03-09, 1394/12/19
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Ethics committee reference number
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IR.Kaums.REC.1394.173
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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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
3
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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
4
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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
5
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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
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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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
8
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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
9
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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
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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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
12
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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
Intervention groups
1
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Description
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Intervention group: Omega-3 fatty acid capsule, 2000 mg omega-3 fatty acid, 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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Kashan 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