(1) Objectives: The purpose of study is introducing a new therapeutic method for accelerating healing with better prognosis in diabetic 2 patients with burn ulcers.
(2) Design: The study population is Diabetic type 2 patients with grade 3 burn ulcers, candidate for amputation in Motahari hospital. This study will be conducted as unicenter case series without blinding and sample size is 13. This would be a pilot study for phase 3 clinical trial.
(3) Setting and conduct: We will use 650 nm red laser light, 2 J/Cm2for the bed of the ulcer and 810 nm infra-red laser light 6 J/Cm2 for the margins along with intravenous laser therapy with 660 nm red light, before and after Split Thickness Skin Graft (STSG) for treating grade 3 burn ulcers in diabetic ulcers.
(4) Intervention: Low level laser therapy before and after Split Thickness Skin Graft.
(5) Participants: Diabetic type 2 patients with grade 3 burn ulcers, candidate for amputation and main exclusion criteria is systematic diseases.
(6) Main outcome measures: The primary outcome is frequency of patients needing amputation surgery and secondary outcome is changes in the size of burn ulcer after treatment.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016011726069N1
Registration date:2016-02-15, 1394/11/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-15, 1394/11/26
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
Skin and stem cell research center
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of effects of low level laser therapy on prognosis of Split Thickness Skin Graft in Type3 Burn ulcers of Diabetic Patients
Public title
Investigation of effects of low level laser therapy on success of Split Thickness Skin Graft in Burn ulcers of Diabetic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with diabetes and grade 3 burn ulcers, according to Wagner classification
Exclusion criteria: were bleeding tendency; presences of gangrene; renal failure; systemic disease; pregnancy; epilepsy; photosensivity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
13
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 Shahid Beheshti University of Medical Sciences
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin , Tehran, Iran. Post code: 198396-3113
City
Tehran
Postal code
198396-3113
Approval date
2015-11-28, 1394/09/07
Ethics committee reference number
IR.SBMU.RAM.REC.13940.363
Health conditions studied
1
Description of health condition studied
Type 3 burn ulcer in diabetic 2 patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Amputation surgery
Timepoint
Before laser therapy, After surgery, After laser therapy, three month after laser therapy
Method of measurement
physician diagnosis
Secondary outcomes
1
Description
Size of type 3 burn ulcer
Timepoint
Before laser therapy, After surgery, After laser therapy, three month after laser therapy
Method of measurement
Pictzar software
Intervention groups
1
Description
Intervention group: Low level laser therapy and Split Thickness Skin Graft
Intervention in control group: No control group
Category
Treatment - Other
2
Description
Control group: -
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari treatment center
Full name of responsible person
Nooshafarin Kazemikhoo
Street address
Shahid Motahari treatment center, Rashid Yasemi street, Valiasr street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Skin and Stem Cell Research Center
Full name of responsible person
Dr Parvin Mansouri
Street address
No;4, Maryam alley, the southern Kamranyeh street.
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 for research of 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
Medical Genetics PhD
Other areas of specialty/work
Street address
No;4, Maryam alley, the southern Kamranyeh street.
City
Tehran
Postal code
14155-6453
Phone
+98 21 2221 2537
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
Medical Genetics PhD
Other areas of specialty/work
Street address
No;4, Maryam alley, the southern Kamranyeh street.
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
Ph D student of epidemiology
Other areas of specialty/work
Street address
No;4, Maryam alley, the southern Kamranyeh street.
City
Tehran
Postal code
14155-6453
Phone
+98 21 2221 2537
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)