Produce and evaluation of the topical effect of simvastatin cream 3% on improving wound healing in diabetic patients compared with placebo: In a randomized, triple -blind, placebo-controlled clinical trial phase 2
Evaluation of the topical effect of Simvastatin on improving wound healing in diabetic patients
Design
A randomized, triple -blind, placebo-controlled clinical trial with factorial groups
Settings and conduct
The formulation of drug and placebo packaged in tubes with quite
the same color and appearance. Patients, physician and analyzer will not know the group of them.The drug group receives a cream containing Simvastatin.The placebo group receives a cream without Simvastatin. Both groups receive standard oral and topical treatment.
Participants/Inclusion and exclusion criteria
Diabetic patients with foot ulcer in grade 2 or 3 and age over 18 years
Intervention groups
The drug group receives a cream containing Simvastatin.The placebo group receives a cream without Simvastatin. Both groups receive standard oral and topical treatment.
Main outcome variables
Wound area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191010045051N1
Registration date:2020-05-30, 1399/03/10
Registration timing:registered_while_recruiting
Last update:2020-05-30, 1399/03/10
Update count:0
Registration date
2020-05-30, 1399/03/10
Registrant information
Name
Mozhde Ghomashbafzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3622 5820
Email address
mozhde.ghomashbaf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2020-07-06, 1399/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Produce and evaluation of the topical effect of simvastatin cream 3% on improving wound healing in diabetic patients compared with placebo: In a randomized, triple -blind, placebo-controlled clinical trial phase 2
Public title
Evaluation of the topical effect of simvastatin on improving wound healing in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with foot ulcer in grade 2 or 3
Exclusion criteria:
Diabetic patients with foot ulcers with a wound surface greater than 10 cm
Patients in need of amputation
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by block method. Six-person blocks were designed including three patients receiving placebo and three patients receiving the drug.The form in the envelope was delivered to the Infectious Disease Physician. Patients, physician and analyzer will not know the group of formulation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The formulation of drug and placebo packaged in tubes with quite
the same color and appearance. Patients, physician and analyzer will not know the group of formulation.
Placebo
Used
Assignment
Parallel
Other design features
The intervention group receives the cream containing simvastatin and the control group receives base cream (without simvastatin). Both groups receive standard treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jondishapour University of Medical Sciences
Street address
Shahid Sherafat Ave., Farhang Blvd., ShushtarTown
City
Shushtar
Province
Khouzestan
Postal code
6451944543
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.AJUMS.REC.1398.141
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E10.5
ICD-10 code description
Type 1 diabetes mellitus with circulatory complications
Primary outcomes
1
Description
Wound area
Timepoint
Measurement of wound area at baseline and 14 and 28 days after topical cream application
Method of measurement
Ruler
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
14 and 28 days after topical cream application
Method of measurement
Number of hospital stay days
Intervention groups
1
Description
Intervention group: Patients in this group twice daily for 4 weeks use 3% Simvastatin cream topically on diabetic foot ulcer.The product formulation is in the form of a cream with a absorbent base and Simvastatin powder has been purchased from Loghman Company.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group twice daily for 4 weeks use the base cream(without simvastatin) topically on diabetic foot ulcer.The base cream has a completely similar formulation to the intervention group and only lacks Simvastatin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Mozhde Ghomashbafzade
Street address
Shahid Sherafat Ave., Farhang Blvd., ShushtarTown
City
Shushtar
Province
Khouzestan
Postal code
6451944543
Phone
+98 61 3622 5820
Email
mozhde.ghomashbaf@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Badavi
Street address
Esfand st
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 8617
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mozhde Ghomashbafzade
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sherafat Ave., Farhang Blvd., ShushtarTown
City
Shushtar
Province
Khouzestan
Postal code
6451944543
Phone
+98 61 3622 5820
Email
mozhde.ghomashbaf@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mozhde Ghomashbafzade
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sherafat Ave., Farhang Blvd., ShushtarTown
City
Shushtar
Province
Khouzestan
Postal code
6451944543
Phone
+98 61 3622 5820
Email
mozhde.ghomashbaf@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mozhde Ghomashbafzade
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sherafat Ave., Farhang Blvd., ShushtarTown
City
Shushtar
Province
Khouzestan
Postal code
6451944543
Phone
+98 61 3622 5820
Email
mozhde.ghomashbaf@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available