Protocol summary
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Study aim
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The aim of this study is to determine the effects of combined magnesium and vitamin E supplementation on metabolic profiles in patients with diabetic foot ulcer.
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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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Sixty patients with diabetic foot ulcer of eligible and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Patients with diabetic foot ulcer and aged 40 to 85 years will be included in this study. Pregnant and breastfed patients, participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months, taking antiinflammatory agents, change in consuming medications throughout the study and patients with history of diseases which influence the development of DFU including chronic trauma, will excluded.
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Intervention groups
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Patients will be assigned into two groups to receive combined magnesium and vitamin E supplements (n=30) or placebo (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:
IRCT2017090533941N21
Registration date:
2017-11-16, 1396/08/25
Registration timing:
retrospective
Last update:
2019-09-23, 1398/07/01
Update count:
1
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Registration date
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2017-11-16, 1396/08/25
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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, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-10-20, 1396/07/28
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Expected recruitment end date
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2017-11-05, 1396/08/14
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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 combined magnesium and vitamin E supplementation compared with the placebo on metabolic profiles in patients with diabetic foot ulcer
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Public title
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Effect of combined magnesium and vitamin E supplementation in treatment of diabetic foot ulcer
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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 grade 3 diabetic foot ulcer
Aged 40 to 85
Exclusion criteria:
Pregnant and breastfed patients
Participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months
Taking anti-inflammatory agents
Change in consuming medications throughout the study
Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
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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 combined magnesium and vitamin E 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 Shahid Beheshti clinic, Kashan 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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2017-10-19, 1396/07/27
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.65
Health conditions studied
1
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Description of health condition studied
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Diabetic foot ulcer
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ICD-10 code
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E14.5
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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
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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
2
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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
3
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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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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
2
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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
3
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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
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 capacity
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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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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
7
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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
8
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Description
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HDL
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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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LDL
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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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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
11
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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
12
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Description
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Magnesium
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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
Intervention groups
1
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Description
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Intervention group: 250 mg magnesium (21st Century, Arizona, USA) and 400 IU vitamin E (Zahravi, Tabriz, Iran) 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 capsule (Barij Essence, Kashan, Iran), 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