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Evaluation of efficacy and safety of topical application of ring worm extract (eisenia foetida) in the treatment of diabetic foot

Protocol summary

Study aim
Determination of the efficacy and safety of topical application of ring worm extract (eisenia foetida) in the treatment of diabetic foot ulcer
Design
Patients are divided into two intervention and control groups by simple randomization method. According to the trial phase of 2-3, the sample size will be in two groups of 20 people. In this study, no blinding will occur.
Settings and conduct
This study will be performed on 20 diabetic patients with Grade 1 and 2 foot ulcer and no blinding will occur in this study. Patients receive usual wound care and treatment and dressing. In addition, the intervention group receives eisenia fida extract under dressing.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 Diabetes Mellitus for at least 5 years, age between 30 to 65 years, Body Mass Index (BMI) between 18 and 35, Wagner grade of 1 and 2. Exclusion criteria: Lack of patient's follow-up, Patient dissatisfaction at each stage of the study, Complications caused by treatments during study, Creation of acute or severe complications of diabetes due to exacerbation of underlying illness, Having other systemic diseases that may affect the ulcer Use of tobacco, alcohol, narcotics, cytotoxic drugs and glucocorticoid and immunosuppressive drugs, Pregnancy and breast feeding, Wagner grade of 3 to 5, HbA1C hemoglobin level of more than 10
Intervention groups
Intervention group: Patients, in addition to usual care and treatment, after daily wound washing with normal saline receive topical eisenia fida extract (G-90 extract) under dressings. Control group: Patients receive regular and standard treatment and daily wound washing with normal saline and also use Vaseline under dressing.
Main outcome variables
Percentage of wound healing, percentage of reduction in wound area (size)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180523039810N1
Registration date: 2018-07-08, 1397/04/17
Registration timing: registered_while_recruiting

Last update: 2018-07-08, 1397/04/17
Update count: 0
Registration date
2018-07-08, 1397/04/17
Registrant information
Name
Bita Kiafar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 3845
Email address
kiafarb@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2020-01-10, 1398/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of topical application of ring worm extract (eisenia foetida) in the treatment of diabetic foot
Public title
Evaluation of efficacy of topical application of ring worm extract in the treatment of diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 Diabetes Mellitus for at least 5 years Age between 30 to 65 years Body Mass Index (BMI) between 18 and 35 Wagner grade of 1 and 2
Exclusion criteria:
Lack of patient's follow-up Patient dissatisfaction at each stage of the study Complications caused by treatments during study Creation of acute or severe complications of diabetes due to exacerbation of underlying illness Having other systemic diseases that may affect the ulcer Use of tobacco, alcohol, narcotics, cytotoxic drugs and glucocorticoid and immunosuppressive drugs. Pregnancy and breast feeding Wagner grade of 3 to 5 HbA1C hemoglobin level of more than 10
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to two groups of intervention and control using simple randomization method.
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Approval date
2018-01-10, 1396/10/20
Ethics committee reference number
IR.MUMS.fm.REC.1396.551

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Rate of patient's wound size improvement
Timepoint
At the beginning of the treatment and monthly follow up until 3 months after first ointment use
Method of measurement
The percentage of recovery is calculated as a percentage of wound size reduction (measured on a millimeter basis) including length-width-depth (by sterile swab) per visit.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 600-mg Clindamycin for every 8 hours and 500-mg ciprofloxacin for every 12 hours are prescribed. Wound washing with normal sterile saline, use of Vaseline on the wound and dressing change twice a day, and control of fasting blood sugar are carried out daily.
Category
Treatment - Drugs

2

Description
Intervention group: 600-mg Clindamycin for every 8 hours and 500-mg ciprofloxacin fore every 12 hours are prescribed. After daily wound washing with normal sterile saline, the topical eisenia foetida extract is used under the dressing. The dressing is changed twice a day, and Fasting blood sugar control is carried out daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Zahra Mazlum Khorasani
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Email
mazloumz@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91357
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Bita Kiafar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3845
Email
kiafarb@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bita Kiafar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3845
Email
kiafarb@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bita Kiafar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Emam Reza hospital, Emam Reza Sq, Ebne-Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3845
Email
kiafarb@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients are made unidentifiable
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
All academic institutes and non-academic industrial institutes which are related to our studies will have access to our data after going through legal procedures.
Under which criteria data/document could be used
In case those people asking for data have the intention of optimizing the study an data and producing more results, access to data is allowed.
From where data/document is obtainable
Through sending an email to the corresponding author, data will be obtainable.
What processes are involved for a request to access data/document
In case someone asks for data, he must first get in contact with the corresponding author for his identity to be fully verified. Then if university allows propagation of data, it will be accessible in 3 months
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