Objective: The aim of this study is to determine the effects of nano-curcumin supplementation on metabolic profiles in patients with diabetic foot ulcer (DFU).
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive supplements (n=30) or placebo (n=30)..
Settings and conduct
Among patients with DFU referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. Intervention period: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients aged 45-85 years diagnosed with DFU. Exclusion Criteria: Patients with Severe renal insufficiency, unwillingness to cooperate.
Intervention groups
Intervention group: 80 mg nano-curcumin (Sina Pharmaceutical Company, Tehran, Iran), daily, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) daily for 12 weeks orally.
Main outcome variables
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles and inflammatory markers (secondary outcomes) will be quantified at study baseline and end-of-trial
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N51
Registration date:2019-03-22, 1398/01/02
Registration timing:retrospective
Last update:2019-03-22, 1398/01/02
Update count:0
Registration date
2019-03-22, 1398/01/02
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-22, 1397/11/02
Expected recruitment end date
2019-02-21, 1397/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of nano-curcumin supplementation on metabolic profiles in patients with diabetic foot ulcer
Public title
Effect of nano-curcumin supplementation in treatment of diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Patients with diabetic foot ulcer
Individuals aged 40 to 85 years..
Exclusion criteria:
Exclusion criteria: patients with Severe renal insufficiency
Unwillingness to cooperate.
Age
From 40 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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 Beheshti 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. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
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
1771844351
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.105
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E11.5
ICD-10 code description
Type 2 diabetes mellitus with circulatory complications
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention