Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of zinc supplementation on metabolic profiles, inflammatory factor and biomarkers of oxidative stress 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 Shahid Beheshti 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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Inclusion Criteria: Patients with diabetic foot according to Wagner criteria higher than 5 years of their disease aged 40 to 85 years.
Exclusion Criteria: The use of substitute treatments including hormone or vitamin or zinc supplements, patients with chronic kidney disease, liver, lung, chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune), pregnant, lactating.
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Intervention groups
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Intervention: Patients will be assigned to receive either zinc supplements (intervention group: n=30) or placebo (control group: n=30).
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Main outcome variables
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Mean ulcer area and markers of insulin metabolism (primary outcomes) and other metabolic profiles (secondary outcomes) will be quantified at baseline and end-of-trial.
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:
IRCT201506215623N46
Registration date:
2015-07-03, 1394/04/12
Registration timing:
registered_while_recruiting
Last update:
2019-10-09, 1398/07/17
Update count:
1
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Registration date
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2015-07-03, 1394/04/12
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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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2015-06-02, 1394/03/12
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Expected recruitment end date
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2015-08-01, 1394/05/10
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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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Effects of zinc supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in patients with diabetic foot
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Public title
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Effects of supplementation in the treatment of 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 according to Wagner criteria higher than 5 years of their disease; aged 40 to 85 years
Exclusion criteria:
The use of substitute treatments including hormone or vitamin or zinc supplements
Patients with chronic kidney disease, liver, lung, chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies
Patients with low immune system ability (autoimmune)
Pregnant
Lactating
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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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3
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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 zinc 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 clinic, 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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2015-06-01, 1394/03/11
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Ethics committee reference number
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IR.Kaums.REC.1394.31
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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E14.5
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ICD-10 code description
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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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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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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
5
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Description
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VLDL-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
6
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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
7
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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
8
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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
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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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
Intervention groups
1
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Description
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Intervention group: Zinc capsule, 50 mg, 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, 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