Evaluation of the effect of gel containing arginine-releasing chitosan nanofibers in the healing of diabetic foot ulcers: a randomized, controlled clinical trial
1. Determining the average wound size and number of erythema cases in experimental and control group patients at the before and end of weeks 1 and 2 of the intervention
2. Comparison of the number of cases of erythema at the end of weeks 1 and 2 of the intervention compared to before the intervention in patients in the experimental and control group
3. Comparison of mean percentage of wound reduction at the end of weeks 1 and 2 of the intervention and control group
4. Determining the number of cases of complete wound healing in the experimental and control group
Design
Random clinical trial with control group
Settings and conduct
1. The study is performed in different wards of Al-Zahra Hospital. 2. Demographic and clinical information of the subjects.
3. Grouping and intervention is done.
4. Using statistical analysis.
Participants/Inclusion and exclusion criteria
1. Grade 1 or 2 diabetic foot ulcers in one or more areas
2. Do not smoke now
3. Do not take anticoagulants and immunosuppressive and supplements effective in wound healing (phenytoin, glucocorticoids, anti-cancer drugs and products containing vitamin C, vitamin A or Zinc) in the last 3 months
4. Do not have chronic vascular insufficiency with a cause other than diabetes and No coagulation disorders (such as hemophilia)
Intervention groups
patients will be randomly divided into experimental and control groups (block randomization method using quadruple blocks). For the experimental group, chitosan gel once a day with dressing and other routine care including debridement, Rinse with normal saline and prescribe antibiotics if necessary and control blood sugar and for people in the control group, a new dressing once a day and routine care. It will be prescribed for 2 weeks.
Main outcome variables
Percentage reduction in wound size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N16
Registration date:2021-03-25, 1400/01/05
Registration timing:prospective
Last update:2021-03-25, 1400/01/05
Update count:0
Registration date
2021-03-25, 1400/01/05
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of gel containing arginine-releasing chitosan nanofibers in the healing of diabetic foot ulcers: a randomized, controlled clinical trial
Public title
Effect of arginine in diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Grade 1 or 2 diabetic foot ulcers in one or more areas
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method using blocks of size 4 will be used. So that all possible sequences of two drug and two placebo in each block will be made with each block being numbered. Then, using random number table, the blocks will be selected randomly and the patients will be assigned to the two groups of drug and placebo according to the the blocks sequences.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-chancellery for research, Isfahan University of Medical Sciences, Hezar-Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-07-09, 1399/04/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.419
Health conditions studied
1
Description of health condition studied
diabetic foot ulcer
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
Ulcer reduction percentage
Timepoint
The beginning of the intervention 7 and 14 days after the intervention
Method of measurement
Ruler
Secondary outcomes
1
Description
The number of cases of erythema around the ulcer
Timepoint
The beginning of the intervention 7 and 14 days after the study
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Chitosan gel (the amount needed to create a layer 3 mm thick on sterile gauze and placed on the wound surface, so as to cover the entire wound surface), once a day with dressing and other routine care including Debridement, rinsing with normal saline and antibiotics will be prescribed for 2 weeks if necessary and blood sugar control. The wound will be washed before applying the gel.
Category
Treatment - Drugs
2
Description
Control group: The control group will be given a new dressing (the type of which will be determined based on the type of wound and only one of them will be included in the study) once a day and routine care for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Rasool Soltani
Street address
Al-Zahra hospital, Soffeh Blvrd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Hagh Joo Javanmard
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
reasearch@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
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