Aim of this study is to evaluate the ability of larvae of Lucilia sericata in removing of Staphilococcus aureus and Pseudomonas aeruginosa in diabetic foot ulcers (In-Vivo study). This study has designed as a clinical trial with control group on 50 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 take routine treatments while the patients in intervention group will take larval therapy as additional method in healing process. Sampling of bacteria will carry out with sterile swabs in both groups simultaneously. Sampling will continue every 48 hours until removing the bacteria in intervention group. Effects of maggot therapy on bacterial infections in diabetic foot ulcers will clear with analysis of results of sampling. Wound discharges were calculated with weighing of dressings on the wounds before and after use.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060328232N1
Registration date:2017-04-02, 1396/01/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-02, 1396/01/13
Registrant information
Name
Kamran Akbarzadeh
Name of organization / entity
School of Public Health, Tehran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 4293 3111
Email address
kakbarzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2017-04-05, 1396/01/16
Expected recruitment end date
2018-04-06, 1397/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on efficacy of maggot therapy on Staphilococcus aureus and Pseudomonas aeruginosa in diabetic foot ulcers
Public title
Efficacy of maggot therapy on Staphilococcus aureus and Pseudomonas aeruginosa in diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with at least one diabetic foot ulcer, second degree (based on Wagner); Presence of at least one of two bacteria (Staphilococcus aureus and Pseudomonas aeruginosa) in the ulcers, patient's age between 30 to 80; At least seven week post ulceration; 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; ُnot 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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block Randomization will use for randomization of the study.
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
1416753955
Approval date
2016-05-24, 1395/03/04
Ethics committee reference number
IR.TUMS.REC.1395.2626
Health conditions studied
1
Description of health condition studied
Chronic ulcer of skin, not elsewhere classified
ICD-10 code
L98.4
ICD-10 code description
Chronic ulcer of skin NOS
Primary outcomes
1
Description
إacterial infections, Staphilococcus aureus and Pseudomonas aeruginosa
Timepoint
sampling before starting of the study and 48 and 96 hours after starting of the study
Method of measurement
culturing of samples in laboratory
Secondary outcomes
1
Description
Amounts of wound secretions
Timepoint
48 and 96 hours after starting of the study
Method of measurement
befors/after weighing of dressings of diabetic foot ulcers of both groups, treatment and control, synchronizingly
Intervention groups
1
Description
Patients in intervention group will receive maggot debridement therapy in addition with routine treatment process for healing of diabetic foot ulcers.
Category
Treatment - Surgery
2
Description
Patients in control group will receive routine healing process for healing of diabetic foot ulcers.
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. Kamran Akbarzadeh
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
طرح تحقیقاتی
Grant code / Reference number
95-01-27-30903
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. Masud Yunesian
Position
Associate Professor - Vice Chancellor of Research of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Department of Environmental Health Engineering, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
1416753955
Phone
+98 21 8163 3698
Fax
+98 21 8163 3686
Email
yunesianm@yahoo.com
Web page address
http://tums.ac.ir/faculties/yunesian
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Kamran Akbarzadeh
Position
PhD - Assistant professor
Other areas of specialty/work
Street address
Department of Medical Entomology and Vector Control, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
1471613151
Phone
+98 21 4293 3075
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Kamran Akbarzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Medical Entomology and Vector Control, School of Public Helath, Tehran University of Medical Sciences
City
Tehran
Postal code
1471613151
Phone
+98 21 4293 3075
Fax
+98 21 8895 1393
Email
kakbarzadeh@tums.ac.ir
Web page address
http://www.tums.ac.ir/faculties/kakbarzadeh
Sharing plan
Deidentified Individual Participant Data Set (IPD)