Lucillia Sericata larval therapy in the treatment of diabetic chronic wounds
Design
70 patients with chronic diabetic ulcers use sterile larvae. Randomization is not real. Only on the basis of the physician's diagnosis and inclusion criteria, the informed consent form is obtained from the candidates and blinding can not be done. The study has no control group.
Settings and conduct
Washing the wound with saline serum, the area around the wound is covered with zinc oxide. Depending on the degree of infection and the size of the wound, a suitable number of larvae are placed on the wound surface and after performing the dressing and fixing it, the patient will be discharged and will return to change the dressing 48 hours later. The results before and after treatment are compared with each other. Patients are examined directly under the supervision of an internal medicine specialist and the results are sent to surgeon colleagues. The place of study is Mahdieh Hamedan specialized clinic.
Participants/Inclusion and exclusion criteria
inclusion criteria: Diabetic patients (more than 15 years old) with chronic wound that signed the informed consent.
Exclusion criteria:
Patients who taking wound healing drugs.
immunosuppress patients.
scares> 5cm.
patients with osteomyelitis, cellulitis and cancers.
patients who needs amputation or flap surgery.
Patients with vascular problems that needs surgery.
Wet wounds.
new wounds.
More than one wound.
smoker
burger disease.
ecxema or skin allergy history.
Chemotherapy or radiotherapy history.
Any sensitivity to special drug.
Intervention groups
In chronic diabetic wounds: The area around the wound is covered with zinc oxide ointment. An appropriate number of sterile larvae are placed on the wound surface and the wound is covered with sterile gauze and a cotton band.
Main outcome variables
Investigation and evaluation of wound size by wound sizing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201012049000N1
Registration date:2020-12-21, 1399/10/01
Registration timing:registered_while_recruiting
Last update:2020-12-21, 1399/10/01
Update count:0
Registration date
2020-12-21, 1399/10/01
Registrant information
Name
Hajar Khazraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1453
Email address
khazraee@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Lucillia Sericata larval therapy in the treatment of diabetic chronic wounds
Public title
Lucillia Sericata larval therapy in the treatment of diabetic chronic wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients (more than 15 years old) with chronic wound that signed the informed consent.
Exclusion criteria:
Consumption of drugs that influence the wound healing.
immunosuppress patients like hemophilia and hepatic disease.
scares> 5cm
patients with osteomyelitis, cellulitis and cancers.
patients who needs amputation or flap surgery.
Patients with vascular problems that needs surgery.
Wet and new wounds.
More than one wound.
smoker or burger disease
Claudication or vascular graft problems.
HbA1C>8
ESR, CRP>+1
anticouagulation therapy.
wound under pressure.
fear of insects.
ecxema or skin allergy history.
Chemotherapy or radiotherapy history.
Any sensitivity to special drug.
Age
From 15 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Colorectal research center, Research tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7193635899
Approval date
2020-07-27, 1399/05/06
Ethics committee reference number
IR.SUMS.REC.1399.826
Health conditions studied
1
Description of health condition studied
Diabetic wound
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Investigation and evaluation of wound size by wound sizing
Timepoint
before intervention and 7 days after
Method of measurement
Evaluation and evaluation of wound size by wound sizing with standard measuring device (strotactic)
Secondary outcomes
1
Description
Inflammation and redness or infection at the site of the wound
Timepoint
before intervention and 7 days after
Method of measurement
Medical visit
Intervention groups
1
Description
Intervention group: 70 patients with diabetic wounds were treated by maggot therapy. First, after washing the wound with saline serum, the area around the wound is covered with zinc oxide ointment. Depending on the degree of infection and the size of the wound, a suitable number of larvae are placed on the wound surface and after performing the dressing and fixing it, the patient will be discharged and will return to change the dressing 48 hours later. The wound size by wound sizing before and after treatment are compared with each other. Patients are examined directly under the supervision of internal medicine specialist and the results are sent to surgeon colleague.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hamedan Clinic
Full name of responsible person
Arash Jafari
Street address
Mahdyeh Clinic, Mahdyeh street, Hamedan
City
Malayer
Province
Hamadan
Postal code
7193635899
Phone
+98 81 3838 0044
Email
arash.jafari87@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaeianzadeh
Street address
Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
rezaiana@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Khazraei
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Colorectal Reserach Center, Research tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
009836281453
Email
hajarkhazraei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Jafari
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Daneshjoo BLV. Malayer
City
Malayer
Province
Hamadan
Postal code
۶۵۷۱۹۶۱۶۶۸
Phone
0098813227878
Email
arash.jafari87@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hajar Khazraei
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Colorectal Research Center, Research tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1453
Email
hajarkhazraei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of Secret data of patients
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Size of wounds
Inflammation, redness
infection
When the data will become available and for how long
one year
To whom data/document is available
Professors
Under which criteria data/document could be used
Future Research
From where data/document is obtainable
First Author
What processes are involved for a request to access data/document