1. Home
  2. Approved trials
  3. » فارسی

Evaluation of Atorvastatin Gel on improvement of diabetic foot ulcer : A Prospective, double-Blind, Randomized,clinical Trial

Protocol summary

Study aim
Preparation of atorvastatin gel formulation and evaluation of its therapeutic effects on the diabetic foot ulcer
Design
A randomized ,double-blind clinical trial with parallel control and intervention groups. Patients will be treated with atorvastatin gel and placebo. The generation of random numbers is done with Random allocation software, and 60 samples will be assigned in 15 blocks of 4.
Settings and conduct
Topical diabetic wound treatment in patients referring to Imam Khomeini hospital in Sari: researcher, participant, clinical caregiver and outcome assessor are blinded in this trial. Diabetic patients with grade 1 and 2 diabetic foot ulcers (based on Wagner's rating) were randomly selected and divided into intervention and control groups. Then, they use the formulations once every three days for a month.
Participants/Inclusion and exclusion criteria
Patients with grade 1 and 2 diabetic wounds (based on Wagner's rating) who are over 18 years old, will be included in the study. Patients with the following conditions will be excluded: having diseases that causing wound healing problems (Like liver and kidney failure, heart failure, various cancers, vasculitis), taking alcohol and cigarettes or any drugs ,the presence of infectious ulcers requiring amputations.
Intervention groups
Control group: Patients in this group will use a placebo gel. Gel formulation without any drugs (formulation without active ingredient, and contains propylene glycol, ethanol, glycerin and carbomer obtained from Dr. Mojallali Industrial Chemical Complex Co.) ,once every 3 days, for one month will be used. Intervention group: Patients in this group will use an atorvastatin 2% gel .Gel formulation containing the drug (active ingredient: atorvastatin 2% powder, Tehran Chemie Pharmaceutical CO) ,once every 3 days, for one month will be used.
Main outcome variables
Permanent pain, changes in the degree of ulcer, wound scope

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100107003014N24
Registration date: 2021-06-18, 1400/03/28
Registration timing: registered_while_recruiting

Last update: 2021-06-18, 1400/03/28
Update count: 0
Registration date
2021-06-18, 1400/03/28
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2022-03-10, 1400/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Atorvastatin Gel on improvement of diabetic foot ulcer : A Prospective, double-Blind, Randomized,clinical Trial
Public title
Evaluation the effects of Atorvastatin on diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Diabetic Wounds Grade 1 and 2 Based on Wagner Ratings Having a single sore in the legs or the ends of the fingers (and the sole of the leg or heel)  Which has lasted at least 4 weeks
Exclusion criteria:
Having diseases that  causing wound healing problems Like liver and kidney failure, heart failure, various cancers, vasculitis Taking alcohol and cigarettes or any drugs The presence of infectious ulcers requiring amputations.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be treated with atorvastatin gel and placebo using the blocking method. The generation of random numbers is done with Random allocation software, and 60 samples will be assigned in 15 blocks of 4. All products used in the study are completely identical in terms of appearance and packaging, and their content will be characterized by a four-digit code.
Blinding (investigator's opinion)
Double blinded
Blinding description
The gel containing the active ingredient and placebo gel is in the same package with the same color and appearance. The gel tubes were coded by the first performer (data analyzer).Therefore, patients, clinical colleagues, and working students do not know any of the codes' meanings. The tubes are randomly selected and used by patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Ethics department of Mazandaran University of Medical Sciences, Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
33971- 48157
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.MAZUMS.REC.1398.1260

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
Changing the degree of ulcer
Timepoint
Wound grade measurement at the beginning of the study (before intervention)  And 7, 14 and 21 days After starting to use a drug gel
Method of measurement
Measuring the size of the wound, the amount of erythema, the amount of pain (VAS criteria) and Irritation

2

Description
Permanent pain
Timepoint
Measuring the amount of pain at the beginning of the study, the first week, the second, third ,and fourth weeks after the start of the study, is evaluated and recorded.
Method of measurement
Visual Analogue Scale

3

Description
Wound Scope
Timepoint
Measuring the wound scope at the beginning of the study, the first week, the second, third ,and fourth weeks after the start of the study, is evaluated and recorded.
Method of measurement
Observation with measuring instruments

Secondary outcomes

1

Description
Side effect during treatment
Timepoint
The type of side effect measured during treatment at the first, second, third and fourth week after the start of treatment.
Method of measurement
observation and according to questionnaire

Intervention groups

1

Description
Control group: Patients in this group (selected randomly and double blindly) will use a placebo gel. Gel formulation without any drugs (formulation without active ingredient, and contains propylene glycol, ethanol, glycerin and carbomer obtained from Dr. Mojallali Industrial Chemical Complex Co.) ,once every 3 days, for one month
Category
Placebo

2

Description
Intervention group: Patients in this group (selected randomly and double blindly) will use an atorvastatin 2% gel .Gel formulation containing the drug(active ingredient: atorvastatin 2% powder obtained from Tehran Chemie Pharmaceutical CO .In addition to the active ingredient, the formulation contains propylene glycol, ethanol, glycerin and carbomer) ,once every 3 days, for one month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Sari
Full name of responsible person
Dr Shahram Ala
Street address
Imam Khomeini Hospital, Amir-Mazandarani street, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
333131-48166
Phone
+98 31 3336 1700
Email
ems115@mazums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research and technology, Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Payambar azam university complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 18 Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
msaeedi@mazums.ac.ir
Web page address
http://pajooheshi.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and technology, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Parham Salehi
Position
Pharmacy student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Payambar Azam university complex, Mazandaran University of Medical Sciences, Km 18 Khazar abad road, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 1354 3083
Fax
Email
parhamsalehi053@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Shahram Ala
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Payambar Azam university complex, Mazandaran University of Medical Sciences, Km 18 Khazar abad road, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 1354 3083
Fax
Email
sh204ala@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Shahram Ala
Position
Clinical pharmacy specialist, Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Payambar Azam university complex, Mazandaran University of Medical Sciences, Km 18 Khazar abad road, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 1354 3083
Fax
Email
sh204ala@yahoo.com
Web page address

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
Not applicable
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
Loading...