Study of the effectiveness of Cord Blood Platelet Gel (CBPG) for treatment of Epidermolysis Bullosa (EB) ulcers
Design
In this study, 15 patients were matched with EB patients' home . The size of the wound caused by EB ,should be on the hand is more than 10 and less than 20 cm*cm. In this intervention, one of the wound EB treat with new dressing (paletlet gel from the cord blood) and another wound on the hand patient is compared with routine treatment at the same time. This intervention is the third phase of the trial. In this intervention, three dressings in three times are performed for each patient at intervals on the other days
Settings and conduct
The location of intervention is in the EB patients' home. In this study blindness was not made and all patients and physicians are aware of the type and wound dressing structure.
Participants/Inclusion and exclusion criteria
Inclusion criteria -
-The wound should be on the hand. Both of genders can be entered this study. -The surface of ulcer should be more than 10 and less than 20 cm2.
Exclusion Criteria
-The patients that have specially diseases such as diabetes , allergy and coagulation of blood.
-The wound that has a very low or high expansion
Intervention groups
The intervention group consists of people who have wound of EB with the entry conditions mentioned above and receive the desired dressing (platelet gel derived from umbilical cord blood),
and the control group is also the same as those who are involved in biological dressing intervention have participated in the routine treatment of EB wounds.The control section is commonly used, including dressing and using silver sulfadiazine, and the intervention section, in addition to the routine treatment, will receive the platelet gel product,
Main outcome variables
- Evaluation the amount of effectiveness platelet gel derived cord blood on the treatment wound of EB
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141007019432N5
Registration date:2018-02-21, 1396/12/02
Registration timing:prospective
Last update:2018-02-21, 1396/12/02
Update count:0
Registration date
2018-02-21, 1396/12/02
Registrant information
Name
Mohammadamir Amirkhani
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 1710
Email address
amirkhani@health.gov.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of Cord Blood Platelet Gel (CBPG) for treatment of Epidermolysis Bullosa (EB) ulcers
Public title
Study of the effectiveness of Cord Blood Platelet Gel (CBPG) for treatment of Epidermolysis Bullosa (EB) ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The wound of EB should be on the hand
The patients that have EB
Both of genders can be entered this study.
The surface of wound should be more than 10 cm2 and less than 20 cm2
Exclusion criteria:
The patients that they have some diseases such as diabetes ,allergy and coagulation of blood .
The wound of EB that has a very low or high expansion .
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
3
platelet derived cord blood are used topically for each person 3 times( every other days),
Randomization (investigator's opinion)
N/A
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
Ethics committee of Tehran University Medical Sience
Street address
Tehran University of Medical Sciences, Cross Qods st, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-12-19, 1396/09/28
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4285
Health conditions studied
1
Description of health condition studied
Wound and Epidermolysis Bullosa
ICD-10 code
Q81
ICD-10 code description
Epidermolysis bullosa
Primary outcomes
1
Description
Formation of wound granulation tissue .
Timepoint
Before intervention and 6 day after the last intervention
Method of measurement
the wound is examined by the pictzar software
2
Description
reduction wound surface and deep
Timepoint
Before intervention and 6 day after the last intervention
Method of measurement
Surface and deep of the wound are examined by the pictzar software
Secondary outcomes
1
Description
Pain from the wound of EB
Timepoint
6 days after the first intervention
Method of measurement
Question and answer from patient.
Intervention groups
1
Description
Intervention group:Including persons who have EB wound on their hands larger than 10 and less than 20 cm2
Category
N/A
2
Description
Control group: At the same time, the same group of patients who have another wound on their hands receive dressing including routine treatment (without the use of a platelet gel derived from umbilical cord blood).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin & Stem Cell Research Center of Medical Tehran University
Full name of responsible person
Mohammad Amir Amirkhani
Street address
Thran -Iran Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
Amirkhani2000@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Presidency for Science and Technology
Full name of responsible person
Alireza Sadeghi
Street address
Vice Presidency for Science and Technology complex , Ladan alley , North shiraz street , Molasadra street
City
Tehran
Province
Tehran
Postal code
0098218 3532371
Phone
+98 21 8353 2371
Email
Emailalireza12580@gmail.com
Grant name
Vice Presidency for Science and Technology
Grant code / Reference number
1595
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Presidency for Science and Technology
Proportion provided by this source
50
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amir Amirkhani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Skin & Stem Cell
Street address
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
Amirkhani2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Mohammadali Nilforoushzadeh
Position
Professor & Head of the Skin & Stem Cell Center
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
+98 21 2220 1710
Email
dr_nilforoush@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Torkamaniha
Position
Master of science in biotechnology
Latest degree
Master
Other areas of specialty/work
Skin & Stem Cell
Street address
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
elham_torkamaniha@yahoo.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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available