Analysis the Effects of Autologous Fibroblast Transplantation and Low-Level Laser Therapy in the Healing Process of Grade 2 Burn wounds in Diabetic patients
(1) Objectives: Evaluate the efficacy of Autologous Fibroblast Transplantation along with Low-Level Laser therapy in grade 2 burn ulcers in diabetic patients. (2) Design: The study population is diabetic patients with type 2 burn ulcers that are hospitalized in Shahid Motahari Burn center and have at least two symmetric ulcers in their body, one ulcer will include in intervention group and the other will use as control randomly by dropping coin. At least five patients will be recruited and the trial will be conducted without blinding, phase three, mono centric trial. (3) Setting and conduct: Laser therapy will be applied for the ulcer which has been randomly selected for intervention group and then fibroblast cells will be sprayed on it. Classic treatment of ulcers will be applied for control group. Ultimately Intervention and control ulcers will be compared regarding time to healing and healing rate. (4) Participants: Diabetic patients with type 2 burn ulcers without systematic diseases or photosensitization. (5) Intervention: Autologous fibroblast transplantation after Low level laser therapy. (6) Main outcome measures: Wound healing, Hypertrophic scar, rate of wound healing
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016050226069N3
Registration date:2016-06-21, 1395/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-21, 1395/04/01
Registrant information
Name
Fereshteh Ansari
Name of organization / entity
Razi Vaccine and Serum Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 26 3405 0400
Email address
ansarif@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Laser application in medical science research centre
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2016-04-22, 1395/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analysis the Effects of Autologous Fibroblast Transplantation and Low-Level Laser Therapy in the Healing Process of Grade 2 Burn wounds in Diabetic patients
Public title
Analysis the Effects of Fibroblast Transplantation and Laser Therapy in the Healing Process of Grade 2 Burn wounds in Diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetic patients with symmetric type 2 burn ulcers
Exclusion criteria: pregnancy; photosensivity; chronic disease that needs medication; malignancy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
5
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
Ethics committee of Tehran University of Medical Sciences
Burn of second degree of head and neck, Burn of second degree of trunk, Burn of second degree of shoulder and upper limb, except wrist and hand, Burn of second degree of wrist and hand, Burn of second degree of hip and lower limb, except ankle and foot,
Primary outcomes
1
Description
Wound size
Timepoint
Before treatment, Two weeks after laser therapy onset, Two weeks after fibroblast transplantation
Method of measurement
Pictzar software
Secondary outcomes
1
Description
Hypertrophic scar
Timepoint
By the end of first, second, third and sixth month after treatment onset
Method of measurement
Vancuver scar scale
2
Description
Rate of healing
Timepoint
After two weeks of laser therapy onset, After two weeks of fibroblast transplantation
Method of measurement
Examination
Intervention groups
1
Description
Intervention group: Laser therapy and Autologous Fibroblast Transplantation
Category
Other
2
Description
Control group: Classic treatment of burn ulcer
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Noshafarin Kazemikhoo
Street address
Shahid Motahari treatment center, Rashid Yasemi street, Valiasr street Tehran Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Skin and stem cell research center
Full name of responsible person
Dr. Mohammad Ali Nilforooshzadeh
Street address
no:4, Maryam Alley, the southern Kamraniyeh, Sadr High way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and stem cell research center
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
Skin and Stem Cell Research Center
Full name of responsible person
Nooshafarin Kazemikhoo
Position
PhD
Other areas of specialty/work
Street address
No;4, Maryam alley, the southern Kamranyeh street. Tehran
City
Tehran
Postal code
Phone
+98 21 2227 8950
Fax
Email
nooshakazemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center
Full name of responsible person
Nooshafarin Kazemikhoo
Position
PhD
Other areas of specialty/work
Street address
No;4, Maryam alley, the southern Kamranyeh street. Tehran
City
Tehran
Postal code
Phone
+98 21 2221 2537
Fax
Email
nooshakazemi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell Research Center
Full name of responsible person
Fereshteh Ansari
Position
PhD
Other areas of specialty/work
Street address
No;4, Maryam alley, the southern Kamranyeh street. Tehran
City
Tehran
Postal code
Phone
Fax
Email
ansarif@ut.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)