Comparison of the effect of 5% hypertonic solution with conventional rinsing method with normal saline in improving diabetic foot
Design
A clinical trial with parallel control group, randomized, phase 3 on 100 patients
Settings and conduct
100 patients with diabetic foot ulcers who referred to Motahari Surgery Clinic in Shiraz in 2015 were entered in the study. The inclusion criteria consisted of patients diagnosed with diabetes type 1 and 2 and ages between 20 to 70 years. DFU patients with osteomyelitis and absence of dorsalis or posterior tibialis pulse, heart failure, fasting blood sugar more than 200, and HbA1C above 7.5 were excluded from the study. The patients were recruited at the Motahari center in which were randomly grouped in the intervention and control group and treatments were modified accordingly. only the Data analyzer was blinded during this study.
Participants/Inclusion and exclusion criteria
Patients with diabetic foot ulcers who referred to Motahari Surgery Clinic in Shiraz in the 2015 were entered in the study. The inclusion criteria consisted of patients diagnosed with diabetes type 1 and 2 and ages between 20 to 70 years. DFU patients with clear gangrene, osteomyelitis, and absence of dorsalis or posterior tibialis pulse, heart failure, fasting blood sugar more than 200, and HbA1C above 7.5 were excluded from the study.
Intervention groups
Rinse diabetic foot ulcer with 5% hypertonic solution as interventional group and comparison with With the conventional method of washing with normal saline as the control group
Main outcome variables
Diabetic foot ulcer healing in terms of size and depth; Microorganism culture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200705048015N1
Registration date:2020-08-05, 1399/05/15
Registration timing:retrospective
Last update:2020-08-05, 1399/05/15
Update count:0
Registration date
2020-08-05, 1399/05/15
Registrant information
Name
Reza Shahriarirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 5344
Email address
r.shahriari1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
2015-03-21, 1394/01/01
Actual recruitment end date
2016-03-20, 1395/01/01
Trial completion date
2016-03-20, 1395/01/01
Scientific title
Comparison of Hypertonic Saline Solution 5% with Normal Saline for Wound Healing in Diabetic Foot Ulcer Patients
Public title
Hypertonic Saline In Diabetic fool Ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with diabetes type 1 and 2
Age between 20 to 70 years old
Diabetic foot ulcer
Exclusion criteria:
Osteomyelitis
Absence of dorsalis or posterior tibialis pulse
Heart failure
Fasting blood sugar more than 200
HbA1C above 7.5
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with a probability of the throw of coin will enter to the intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134853185
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
IR.SUMS.MED.REC.1395.12
Health conditions studied
1
Description of health condition studied
Diabetic foot Ulcer
ICD-10 code
E11.5
ICD-10 code description
Diabetes mellitus With peripheral circulatory complications
Primary outcomes
1
Description
Healing diabetic foot ulcers
Timepoint
6 weeks
Method of measurement
Size and depth of the ulcer
Secondary outcomes
1
Description
Diabetic foot ulcer infection
Timepoint
6 weeks
Method of measurement
Obtaining culture from diabetic foot ulcer
Intervention groups
1
Description
Intervention group: Patients' foot ulcer was cleansed and treated with a 5% hypertonic saline solution in the first group for 6 weeks and 3 times a day. The solution of hypertonic saline was prepared by dissolving 50 grams of salt per liter of cooled water and used 3 times a day. The patients were again examined for size and depth of the ulcer after 6 weeks and the results were recorded. Patients were visited weekly for up to 6 weeks. The amount of solution used was measured and administered to the patient using a measuring container.At the end of the study, the patients were sampled for microbial culture. In the course of admission, each patient who needs a debridement were excluded from the study. The size of the patient's ulcer was again calculated as the longitudinal and transverse diameter of the ulcer with a photograph taken at a distance of 30 centimeters.
Category
Treatment - Other
2
Description
Control group:This group was treated with normal saline 0.9%. The patients were again examined for size and depth of the ulcer after 6 weeks and the results were recorded. Patients were visited weekly for up to 6 weeks. The amount of solution used was measured and administered to the patient using a measuring container.At the end of the study, the patients were sampled for microbial culture. In the course of admission, each patient who needs a debridement were excluded from the study. The size of the patient's ulcer was again calculated as the longitudinal and transverse diameter of the ulcer with a photograph taken at a distance of 30 centimeters.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Bizhan Ziaian
Street address
Namazi square, Motahari Clinic
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
r.shahriari1995@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Zand Street, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3212 2430
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
https://research.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bizhan Ziaian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Namazi Hospital, Zand street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
ziaianb@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Bizhan Ziaiain
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Namazi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4332
Email
ziaianb@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Shahriarirad
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shiraz University of medical sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3230 7809
Email
r.shahriari1995@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
None to declare
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data will be published after deidentification
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
People who are engaged in the this topic are able to ask for the information
Under which criteria data/document could be used
Data of the participant can be requested from the authors. Please write to the correspondence if you are interested in such data.
From where data/document is obtainable
Please write to the correspondence if you are interested in such data.
What processes are involved for a request to access data/document
Data will be sent on reasonable request within a few days via email