Comparison of the effect of dressing with manuka honey and ordinary dressing on the process of repairing diabetic foot ulcers
Design
The trial has a control group, with parallel groups, one blind, non-random allocation, and a sample size of 40 people.
Settings and conduct
The present study will be conducted in Vasei Hospital in Sabzevar. Participants in the study and all medical personnel working in the department will not know the type of groups and the allocation of samples.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age 40 to 80 years.
2. Type 2 diabetes.
3. Blood sugar between 150-400.
Non-Inclusion criteria:
1. No patient consent to participate in the study.
2. A history of high blood sugar of 400 mg.
3. Having various chronic diseases.
4. Need to scrape into debridement.
5. History of addiction use.
6. Mental disability.
Intervention groups
In the intervention group, dressing will be done with Manuka honey and in the usual dressing control group.
Main outcome variables
Diabetic foot ulcer examination.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171219037967N2
Registration date:2019-09-13, 1398/06/22
Registration timing:retrospective
Last update:2019-09-13, 1398/06/22
Update count:0
Registration date
2019-09-13, 1398/06/22
Registrant information
Name
Mehdi Jamalinik
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4441 5745
Email address
mhd.niki67@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Dressing with Manuka honey and Ordinary dressing on the process of repairing diabetic foot ulcers
Public title
Comparison of the effect of Manuka honey and ordinary dressings on diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between the ages of 40 and 80 years hospitalized.
Having Type 2 Diabetes Based on Patient Medical Record and Certified Physician.
The blood glucose level is between 150-400.
Exclusion criteria:
Patient dissatisfaction with participation in the study.
Having a history of high blood sugar of 400 mg over a period of 6 months to one year.
Having multiple chronic illnesses.
Need to wound debridement.
having drug addiction
Mental disability
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Assignment of samples will be randomly divided into two groups of intervention and control, and the participants in the study, as well as the health care staff present in the department (all doctors and nurses) will never know how to assign samples and research groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Nuclear Martyrs Boulevard, Campus of Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
233445555
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications
Primary outcomes
1
Description
Assessment and management of foot ulcers in diabetic patients
Timepoint
Every day for one month
Method of measurement
Detailed daily examination of the wound by an infectious disease specialist
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Normal and routine wound dressing.
Category
Treatment - Other
2
Description
Intervention group: dressing for Diabetic foot ulcer with manuka honey 100% ointment prepared from Iran Pharmis Company.