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Comparison of the effectiveness of maggot therapy in removing necrotic tissues and pathogenic bacteria in diabetic foot ulcers in grade of Wagner 2

Protocol summary

Study aim
To evaluate the efficacy of Maggot Therapy with Lucilia sericata in treatment of diabetic foot ulcers as a clinical trial
Design
Block randomization method will be used for random allocation. The blocks size will be 4 and for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, dice drooped and the bloc number will be selected. this procedure continued to completed the allocation and reached to sample size.
Settings and conduct
This study was conducted as a clinical trial study with 56 patients who referred to diabetes clinic of Shahid Beheshti Hospital affiliated to Qom University of Medical Sciences. Patients must sign an informed consent form before entering the study. Blinding will not be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with at least one diabetic foot ulcer, no need for anticoagulant or steroid pharmaceutics; ُnot addicted to alcohol or opium. Exclusion criteria: Acquiring sever diseases such as heart disorders and so on, sever pain during maggot therapy, sever and uncontrolled fever during maggot therapy
Intervention groups
Patients entered into the study are divided into two groups of control and intervention. Both groups will take routine treatments for diabetic foot ulcers. Routine therapy involves local and systemic measures, including blood glucose uptake, debridement, wet dressing, nutritional support, and antibiotic therapy. Patients in the intervention group, in addition to routine therapies, will receive maggot therapy as a method along with routine methods. Patients in the control group will be treated with routine methods only.
Main outcome variables
Removing of necrotic tissues; appearing of granulated tissues; removing of main bacteria from the wounds

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170723035248N2
Registration date: 2018-03-21, 1397/01/01
Registration timing: registered_while_recruiting

Last update: 2018-03-21, 1397/01/01
Update count: 0
Registration date
2018-03-21, 1397/01/01
Registrant information
Name
Abedin Saghafipour
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3784 2228
Email address
asaghafi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Qom University of Medical Sciences
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of maggot therapy in removing necrotic tissues and pathogenic bacteria in diabetic foot ulcers in grade of Wagner 2
Public title
Efficacy of maggot therapy on diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have at least one diabetic foot ulcer (grade s, Wagners’ classification). Patients who have not osteomeyelies. Patients who have not need to be hospitalized. Patients who have not acute or other chronic diseases. Patients who have not need anticoagulant or steroid pharmaceutics. Patients who have ُnot addicted to alcohol or opium.
Exclusion criteria:
Patients who have sever diseases such as heart disorders and so on during maggot Therapy. Patients who have sever pain during maggot Therapy. Patients who get sever and un-controlled fever during maggot therapy. Patients with maceration around the wound after each interval of maggot therapy. Patients who need emergent hospitalization during or after of each interval of maggot therapy. Patients who take bleeding during maggot therapy.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 56
Actual sample size reached: 56
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, block randomization method will be used for random allocation. The blocks size will be 4 and for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, ِDice drooped and the bloc number will be selected. this procedure continued to completed the allocation and reached to sample size.
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 Qom University of Medical Sciences
Street address
Ghoum University of Medical Sciences, Safa Shahr Avenue, Building of Research and Technology Deputy
City
Ghoum
Province
Ghoum
Postal code
37169-87366
Approval date
2017-07-04, 1396/04/13
Ethics committee reference number
IR.MUQ.REC.1396.41

Health conditions studied

1

Description of health condition studied
Diabetic foot ulcer
ICD-10 code
L98.4
ICD-10 code description
Chronic ulcer of skin NOS

Primary outcomes

1

Description
measuring surface of necrotic tissue
Timepoint
48 and 96 hours after treatment
Method of measurement
photographing and measuring by MATLAB 1.6, the mathworks Inc, natic, ma, 2000

Secondary outcomes

1

Description
Bacterial infections, Staphilococcus aureus and Pseudomonas aeruginosa
Timepoint
48 and 96 hours after treatment
Method of measurement
culturing of samples in laboratory

Intervention groups

1

Description
Intervention group: In addition to receiving the routine treatment that the control group will receive, the prescription of the larvae of the flies (Lucilia sericata larvae) is also used to treat diabetic foot ulcer. Routine therapy involves local and systemic measures, including blood glucose uptake, debridement, wet dressing, nutritional support, and antibiotic therapy. The number of larvae per wound in order to maggot therapy as process in healing of wounds, varies. It is depending on the extent and depth of the wound and the degree of infection in different parts of the damaged site in the wound. But usually, there are 8 to 10 larvae per cm2 of ulcer. Interventions will be done every 48-72 hours. Interventions in this plan will only be carried out by a licensed medical staff such as a doctor and a nurse. In this plan, the duration of the intervention will be until complete remove of the necrotic tissue.
Category
Treatment - Surgery

2

Description
Control group: They will receive only routine treatment for diabetic foot ulcers.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mahmood Parham
Street address
Ghoum University of Medical Sciences, Safa Shahr Avenue, Building of Research and Technology Deputy
City
Ghoum
Province
Ghoum
Postal code
37169-87366
Phone
+98 25 3285 4011
Fax
+98 25 3783 3361
Email
dr.hosseinsaghafi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Ghoum University of Medical Sciences, Safa Shahr Avenue, Building of Research and Technology Deputy
City
Ghoum
Province
Ghoum
Postal code
37169-87366
Phone
+98 25 3285 4011
Fax
+98 25 3783 3361
Email
dr.hosseinsaghafi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Abedin Saghafipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Faculty of Health, Ghoum University of Medical Sciences, Rohollah Square
City
Ghoum
Province
Ghoum
Postal code
3711675549
Phone
+98 25 3784 2228
Fax
+98 25 3783 3361
Email
asaghafi@muq.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Akbarzadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Department of Medical Entomology, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14155-6446
Phone
+98 21 8895 1393
Fax
+98 21 8895 1393
Email
kakbarzadeh@tums.ac.ir
Web page address
http://tums.ac.ir/faculties/kakbarzadeh

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Abedin Saghafipour
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Medical Entomology
Street address
Faculty of Health., Ghoum University of Medical Scineces, Rohollah Square
City
Ghoum
Province
Ghoum
Postal code
3711675549
Phone
+98 25 3784 2228
Fax
+98 25 3783 3361
Email
asaghafi@muq.ac.ir
Web page address

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic data including age and gender
When the data will become available and for how long
Starting of sharing one year after case selection.
To whom data/document is available
Data will available for scientists working in academic institutions or people working in businesses can also apply to receive it.
Under which criteria data/document could be used
Using of the shared data will be free for use in academic research.
From where data/document is obtainable
Deputy of Research and Technology of Ghoum University of Medical Sciences
What processes are involved for a request to access data/document
People who need to have data of this study should write formally to Deputy of Research and Technology of Ghoum University of Medical Sciences.
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