Aim of this study is to evaluate the efficacy of Biobag (disinfected larvae of Lucilia sericata in bag) as a new tool in maggot therapy of diabetic foot ulcers (In-Vivo study). This study has designed as a clinical trial with control group on 52 patients which will refer to wound clinic of Iranian Academic Center for Education, Culture and Research of Tehran University of Medical Sciences. The patients will sign an informed consent before entering the project. Selected patients will divide in half into intervention group and control group. The patients in both groups will receive routine treatment of diabetic foot ulcers. Patients in control group will receive maggot therapy beside of routine treatment process. Patients in intervention group will receive Biobag as an additional method in healing process. Measuring of surface of necrotic tissue and granulated tissue will do at a 48 hours interval in both groups. Reducing of necrotic tissues and appearing or increase of granulated tissue will calculate and compare.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017053134272N1
Registration date:2017-09-11, 1396/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-11, 1396/06/20
Registrant information
Name
Javad Rafinejad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3121
Email address
jrafinejad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Tehran University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on efficacy of Biobag (disinfected larvae of Lucilia sericata in bag) as new tool in maggot therapy of diabetic foot ulcers
Public title
Efficacy of Biobag in treatment of diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient's age between 30 - 80, patients with at least one diabetic foot ulcer, second degree (based on Wagner); having ankle-brachial index (ABI) more than 0.6 or two clear beats on ulcerated leg; not need to be hospitalized; lack of other dangerous diseases; no need for anticoagulant or steroid pharmaceutics; nُot addicted to alcohol or opium; no entomophobia; to sign the consent.
Exclusion criteria: Having sever diseases such as heart disorders and so on, Sever pain during maggot Therapy, Sever and un-controlled fever during maggot therapy, maceration around the wound after each interval of maggot therapy, Emergent hospitalization during or after of each interval of maggot therapy, Bleeding during maggot therapy
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
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
Committee of Ethics in Research of Vice Chancellor of Research, Tehran University of Medical Science
Street address
Enghelab street, Ghods street, Tehran University of Medical Sciences
City
Tehran
Postal code
1417613151
Approval date
2017-01-25, 1395/11/06
Ethics committee reference number
IR.TUMS.SPH.REC.1395.1533
Health conditions studied
1
Description of health condition studied
Chronic ulcer of skin NOS
ICD-10 code
L98.4
ICD-10 code description
Chronic ulcer of skin, not elsewhere classified
Primary outcomes
1
Description
measuring of 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
measuring of granulated tissue
Timepoint
48 and 96 hours after treatment
Method of measurement
photgraphing and measuring by MATLAB 1.6, the mathworks Inc, natic, ma, 2000
Intervention groups
1
Description
Patients in control group will receive maggot therapy beside of routine treatment process.
Category
Treatment - Surgery
2
Description
Patients in intervention group will receive Biobag as an additional method in healing process.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Wound Treatment Clinic of Iranian Academic Center for Education, Culture and Research
Full name of responsible person
Dr. Seyyed Mehdi Tabaee
Street address
Enghaleb street, Felestin street, Nazari avenue, No 17
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Tehran University of Medical Sciences
Full name of responsible person
Mrs Ahadi
Street address
Enghelab street, Ghods Street, Vice Chancellor of Research, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Javad Rafinejad
Position
Professor
Other areas of specialty/work
Street address
Department of Medical Entomology, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
1417613151
Phone
+98 21 4293 3121
Fax
Email
jrafinejad@tums.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
Dr. Kamran Akbarzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Medical Entomology, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
1417613151
Phone
+98 21 4293 3121
Fax
Email
kakbarzadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Javad Rafinejad
Position
Professor
Other areas of specialty/work
Street address
Department of Medical Entomology, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
1417613151
Phone
+98 21 4293 3121
Fax
Email
jrafinejad@tums.ac.irjrafinejad@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)