Evaluating the effectiveness of topical simvastatin 2% ointment on the healing of diabetic foot ulcer
Comparing the effectiveness of simvastatin 2% ointment with the routine treatment
The rate of side effects caused by simvastatin 2% ointment
Design
A phase 1, randomized and single blinded clinical trial with control group on 60 patients with grade 2 diabetic foot ulcer
Settings and conduct
Group 1: Patients with grade 2 diabetic foot ulcer and admitted to Rasoul Akram Hospital for 14 days will be treated with simvastatin 2% ointment twice a day.
Group 2: In the control group, patients use simple foam dressing.
Participants/Inclusion and exclusion criteria
The age of the patient should not be less than 18 years and not more than 70 years.
A patient with Wagner grade 2 diabetic foot ulcer
Not using topical antibiotics and other topical treatment for the patient
A patient with no symptoms of septicemia, septic shock or organ dysfunction syndrome
Intervention groups
Patients are divided into two groups of 30 patients, treatment and control. Simvastatin 2% ointment will be used in the treatment group, and simple foam dressing will be used in the control group. In both treatment and control groups, the treatment will continue twice a day for two weeks. All wounds are covered with Vaseline gauze.
Main outcome variables
1. Grading the type and severity of the wound 2. Evaluating the apparent progress of wound healing 3. Evaluation of drug side effects 4. Blood factors related to infection and inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200325046854N3
Registration date:2023-10-28, 1402/08/06
Registration timing:prospective
Last update:2023-10-28, 1402/08/06
Update count:0
Registration date
2023-10-28, 1402/08/06
Registrant information
Name
Maryam Farasatinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4460 4800
Email address
maryfarasati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-16, 1402/08/25
Expected recruitment end date
2024-02-14, 1402/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of topical simvastatin 2% ointment on the healing of diabetic foot ulcer in comparison with the routine treatment
Public title
topical simvastatin in diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A patient with Wagner grade 2 diabetic foot ulcer
Not using topical antibiotics for the patient
A patient with no symptoms of septicemia, septic shock or organ dysfunction syndrome
The age of the patient should not be less than 18 years and not more than 70 years.
Exclusion criteria:
Receive other topical treatments for diabetic foot ulcers
Age
From 18 years old to 70 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Among the patients referred to the clinic or hospitalized in Rasoul Akram Hospital, numbering is done in odd and even numbers. Odd patients will be in the treatment group and even patients will be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant does not know the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad Tehran Medical Sciences University - Pharmacy and Pharmac
Street address
shariati St, Gholhak
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
IR.IAU.PS.REC.1401.439
Health conditions studied
1
Description of health condition studied
diabetic foot ulcer
ICD-10 code
E08.621
ICD-10 code description
Diabetes mellitus due to underlying condition with foot ulcer
Primary outcomes
1
Description
Grading the type and severity of the wound
Timepoint
Day 0, 7 and 14
Method of measurement
The size, amount of discharge and smell of the wound
2
Description
Evaluating the apparent progress of wound healing
Timepoint
Day 0, 7 and 14
Method of measurement
Imaging
Secondary outcomes
1
Description
Possible side effects
Timepoint
Day 0, 7 and 14
Method of measurement
Descriptive
Intervention groups
1
Description
Intervention group:Patients in Rasoul Akram Hospital, diagnosed with Wagner grade 2 diabetic foot ulcer, will be treated with simvastatin 2% ointment. Ointment will be administered twice a day for 2 weeks and the wound will be covered with Vaseline gauze.
Category
Treatment - Drugs
2
Description
Control group: Patients in Rasoul Akram Hospital, diagnosed with Wagner grade 2 diabetic foot ulcer, will be treated with Simple foam dressing for 2 weeks and twice a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Zeynab Yasin
Street address
Niyayesh St, Sattar Khan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 1000
Email
zeynab.yasin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeynab yasin
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2397
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Islamic Azad University
Full name of responsible person
Fatemeh Jamali
Position
Pharmacy student
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy and Pharmaceutical Sciences - Islamic Azad University, Gholhak, Shariati St