In this research, 20eligible patients referring to diabetic wounds were chosen and assigned to the intervention group.
Settings and conduct
This study is done in the skin and leprosy center.20 patients are selected for the study. Patient tracking is done up to 12 weeks after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetic ulcer with at least1cm2 with gradeIIWagner calcification -Over 5ABI-Over3MDNS Exclusion criteria: Dermatitis-Patients who received other treatments for their diabetic ulcers like antibiotic therapy- Infectious diabetic wounds.
Intervention groups
According to the entry and exit criteria,20patients are selected for the study. Each patient receives training for wound care and training related to washing and wound dressing at intervals to visit the center. Patient tracking is done up to 12 weeks after treatment or complete recovery. Instructions for wound care in the study: After wearing sterile gloves and washing the powder with sterile water, the wound should only be washed with normal saline or sterile water. If you see necrotic tissue, perform a gentle cleansing with saline-soaked gas. Wash exposed to open air for 15-15 minutes. Avoid wound drying. A half centimeter thick layer of gel is placed on the wound, without contact with the hand or any other means. Then add a multi-layer sterile gauze on the wound and apply with 3M anti-allergenic adhesive. Patient education: Wound washing and wound dressing. Exercise lower limb movement while sitting and lying. Use underarm cane to prevent pressure on the wound. The need for a weekly visit to a research center to receive regular medication and track the recovery rate and weekly imaging.
Main outcome variables
Accelerating the repair of ischemic, necrotic, gangrene, osteomyelitis, pressure ulcers, fistulas, surgical and skin grafts.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170903036045N2
Registration date:2020-04-17, 1399/01/29
Registration timing:retrospective
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Farid Dorkoosh
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 9440
Email address
dorkoosh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation, evaluation, and comparison of two topical semisolid formulations containing insulin for improvement and acceleration of diabetic wound.
Public title
Preparation, evaluation and comparison of two topical semisolid formulations containing insulin for improvement and acceleration of diabetic wound.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18
Diabetic ulcer with at least 1 cm2 with grade II Wagner calcification
Over 5 ABI
Over 3 MDNS
Willingness to participate in the study
Exclusion criteria:
Nursing and pregnant woman
Immunosuppressive therapy
Immunosuppressive disorder
Kidney disorder (Cr>2.5)
CHF, CABG, Cardiomyopathy
HA1C>10
Smoking
Alcohol and drugs
Dermatitis
Patients who received other treatments for their diabetic ulcers like antibiotic therapy
Infectious diabetic wounds
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
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 Tehran university of medical sciences
Street address
Floor 13th, block A, Headquarter of the ministery of health and medical education, Simaye Iran St, Qods town
City
tehran
Province
Tehran
Postal code
1467664961
Approval date
2020-02-11, 1398/11/22
Ethics committee reference number
IR.TUMS.VCR.REC.1398.917
Health conditions studied
1
Description of health condition studied
Diabetic wounds
ICD-10 code
s81
ICD-10 code description
Open wound of knee and lower leg
Primary outcomes
1
Description
Wound surface
Timepoint
Every weeks up to 12 weeks
Method of measurement
Ealipers
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1) Wound should be washed with sterile NS or sterile water after wearing sterile gloves. 2) If there is any necrosis, debridement should be done gently by sterile gauze pads (wet with sterile NS). 3) After washing, wounds should be allowed to dry in room atmosphere 4) Wound should not be dried by using any gauze or other means 5) A 0.5 mm thick layer of insulin gel (100 IU per mL of insulin) should be applied on the surface of the wound without any contact with the hand or another applicator 6) A suitable piece of sterile Gauze layers should be placed on the surface of the wound and be dressed by anti-allergic 3M tape.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training of skin diseas and leprosy
Full name of responsible person
Dr. Alireza firoz
Street address
No. 415, Shahid naderi street, Taleghani Ave
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2221
Email
firozali@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Esmaeel Haririan
Street address
Enghelab Sq, Tehran, Iran
City
TEHRAN
Province
Tehran
Postal code
1417614411
Phone
+98 21 6648 2607
Email
mbrc@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Skin and leprosy center
Full name of responsible person
Dr.mohamad ali palar
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 415, Shahid Naderi street, Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 3804
Email
mohammadali.palar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and leprosy center
Full name of responsible person
Dr.alireza firooz
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Skin specialist
Street address
Center for research and training in skin disease and leprosy
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8896 3804
Email
firozali@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.soheil haddadzadegan
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No23, second avenue, gisha, keyhanpharmacy
City
Tehran
Province
Tehran
Postal code
1466873888
Phone
+98 21 8827 7635
Email
soheilhaddad74@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
These files will be available after completion of the study: Study protocol Consent form Report.
When the data will become available and for how long
Data will be available 6 months after completion of the study.
To whom data/document is available
Researchers of academic institutions and industry.
Under which criteria data/document could be used
Just for review of the study.
From where data/document is obtainable
Dr. Alireza Firoz Email: firozali@sina.tums.ac.ir Center for research and training of skin and leprosy.
What processes are involved for a request to access data/document
In order to request information regarding this clinical trial, send an email to the mentioned address containing the following information: Name and family name, education and field of work/study, the reason for requesting the information Based on the requested data, your request will be replied as soon as possible.