Evaluation of the Effectiveness of topical cream 3% Simvastatin on the percentage of wound healing of grade 2 and 3 Bedsore in Diabetic and non_diabetic people compared to Placebo and Standard treatment
Evaluation of the clinical effect of topical cream of Simvastatin on bedsore healing ratio
Design
A randomized controlled clinical trial with single, double blind, phase 2 on 20 patients
Settings and conduct
The study site is Taleghani Hospital in Ahwaz,wound clinic. Dimensions of patient's Bedsores are measured by clinical caregiver using the Wound healing ratio formula. The caregiver and the patient are blind and therapeutic creams based on codes on creams and the codes inside the envelope is given to the patients.
Participants/Inclusion and exclusion criteria
Entry conditions: informed consent, Diabetes and bedsore,No entry conditions: allergy to Statins and pregnant or lactating
Intervention groups
In the intervention group the therapeutic effect of topical simvastatin is investigated.The control group has no active ingredient to compare the efficacy.
Main outcome variables
Reduce the size of the patient's wound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200602047634N1
Registration date:2020-06-05, 1399/03/16
Registration timing:prospective
Last update:2020-06-05, 1399/03/16
Update count:0
Registration date
2020-06-05, 1399/03/16
Registrant information
Name
Afarin Aghajari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5235 5757
Email address
afarinaghajari01@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-13, 1399/03/24
Expected recruitment end date
2020-07-14, 1399/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of topical cream 3% Simvastatin on the percentage of wound healing of grade 2 and 3 Bedsore in Diabetic and non_diabetic people compared to Placebo and Standard treatment
Public title
Effect of topical Simvastatin in treatment of Bedsore
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who sign informed consent
Patients with Diabetes
Patients with grade 2 or 3 Bedsores
Exclusion criteria:
Patients with a history of allergy to Statins
Patients who are pregnant or lactating
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The method of block randomization is that people are divided into four blocks and each block after entering the treatment room, the random permutations are written in a sealed envelope like Placebo Placebo Medicine Medicine, Medicine Placebo Medicine Placebo and..., take the Drug and give it to the clinical caregiver and the clinical caregiver without knowing the coding in the envelope gives the Sick. The Placebo code is A and the Medicine code is B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Initially, the code for the Placebo is considered by the researcher to be Placebo A and Medicine B.In sealed envelopes,the Researcher writes the code as random permutations and gives clinical caregiver so that patients can pick up an envelope of their choice then the clinical caregiver based on the random permutation and the code on the cream tube gives patients Placebo or Medicine.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comqmittee of Ahvaz University of Medical Sciences
Street address
Golestan st, Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-05-18, 1398/02/28
Ethics committee reference number
IR.AJUMS.REC.1398.178
Health conditions studied
1
Description of health condition studied
Bed sore
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
30% reduction in wound size
Timepoint
Measure the size of the wound at the beginning of the study and 7, 14 and 21 days after starting topical Simvastatin
Method of measurement
Ruler of wound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical cream containing 3% Simvastatin, apply on clean wound Twice daily, a 50 gram cream every week, treatment for 3 weeks
Category
Treatment - Drugs
2
Description
Control group: Topical cream without Simvastatin, with Water- absorbing base, in order to compare with the treatment group, apply on clean wound Twice daily, a 50 gram cream every week, treatment for 3 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Afarin Aghajari
Street address
Mostaan St, Amaniye
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3554 0255
Email
afarinaghajari01@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
Ahvaz Jondishapour University of Medical Sciences, Esfand St, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 8617 3221
Email
itc@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
Afarin Aghajari
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
6 plaque, Hakim 3 alley, sardaran shahid St, phase 2
City
Mahshahr
Province
Khouzestan
Postal code
6351897799
Phone
+98 61 5235 5757
Email
afarinaghajari01@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Ganji
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ahvaz Jondishapour University of Medical Sciences, Esfand St, Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61956-73654
Phone
+98 61 8617 3221
Email
Rg.pharm777@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Afarin Aghajari
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
6 plaque, Hakim 3 Alley, Sardaran shahid St, Phase 2
City
Mahshahr
Province
Khouzestan
Postal code
6351897799
Phone
+98 61 5235 5757
Email
afarinaghajari01@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