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. Study design: Randomized double-blinded controlled clinical trial. Inclusion Criteria: Patients with diabetic foot according to Wagner criteria, higher than 5 years of their disease and aged 35 to 75 years will be included in this study. Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements, patients with chronic kidney disease, liver, lung and chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune) and pregnant or lactating women will be included in this study. Population and sample size: 60 patients with diabetic foot of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either zinc supplements (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and End Date of Intervention: 3 months (Sebtember 7, 2015-December 7, 2015). Outcomes: Fasting plasma glucose (FPG), serum insulin, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH) will be meseaured at study baseline and End-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506215623N46
Registration date:2015-07-03, 1394/04/12
Registration timing:prospective
Last update:
Update count:1
Registration date
2015-07-03, 1394/04/12
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
2015-07-06, 1394/04/15
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of zinc supplementation on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in patients with diabetic foot
Public title
Effects of supplementation in the treatment of diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with diabetic foot according to Wagner criteria; higher than 5 years of their disease; aged 35 to 75 years.
Exclusion Criteria: The use of substitute treatments including hormone or vitamin 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.
Age
From 35 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2015-06-01, 1394/03/11
Ethics committee reference number
IR.Kaums.REC.1394.31
Health conditions studied
1
Description of health condition studied
Diabetic foot
ICD-10 code
E14.5
ICD-10 code description
With peripheral circulatory complications
Primary outcomes
1
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
2
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
3
Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
4
Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
5
Description
Triglyceride
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
6
Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
7
Description
HDL-cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
8
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
9
Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
10
Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
11
Description
Added at 2016-10-17: Ulcer length, width and depth
Timepoint
Added at 2016-10-17: Baseline and 12 weeks after the intervention.