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Effect of Low level laser with Ga-As (904 nm) on expression of angiogenic factors (VEGF, NO, VEGFR-2, HIF-1α), Oxygen saturation of peripheral blood and wound surface area in ischemic diabetic foot ulcers

Protocol summary

Summary
Defects in vessels and neovascularization makes diabetic chronic wounds difficult to treat. Reduce the production of angiogenic factors is involved an important inhibit in the construction of new vessels in diabetic foot ulcers. Low level laser therapy as a therapeutic treatment modality can effect on angiogenesis and release of its factor in wound site. The purpose of this study is to examine the changes of blood serum factors including VEGF, VEGFReceptor-2, NO and HIF-1α, measurements of Oxygen saturation of peripheral blood in around wound and wound surface area in ischemic diabetic foot ulcers after LLLT, Therefore, 30 patients with ischemic diabetic foot ulcer were randomly and single blind(patients) divided into two groups: Ga-As laser (No=15) and placebo (No=12). In laser group, Ga-As laser (2 j/cm2) with conventional therapy and in placebo group, conventional therapy with laser therapy While it is turned off were applied, for 12 sessions, every other day . On the first and last treatment session, before and after intervention, Blood sample are taken from all patients in the both groups for VEGF, VEGFreceptor-2, NO and HIF-1α measurement. Oxygen saturation of peripheral blood and wound surface area are measured at first, sixth and twelfth treatment sessions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051717723N1
Registration date: 2015-05-08, 1394/02/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-08, 1394/02/18
Registrant information
Name
Mah sa Hoseini Sanati
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4509
Email address
mahsa.hoseinisanati@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbia Modares University, Tehran
Expected recruitment start date
2015-04-05, 1394/01/16
Expected recruitment end date
2015-11-06, 1394/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Low level laser with Ga-As (904 nm) on expression of angiogenic factors (VEGF, NO, VEGFR-2, HIF-1α), Oxygen saturation of peripheral blood and wound surface area in ischemic diabetic foot ulcers
Public title
Low level laser effect on improving the blood flow in diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: 1. Diabetic patients with ischemic diabetic foot ulcers (of both sexes) aged 40 to 60 years 2. 32> BMI> 25 3.Wagner grade 2 diabetic ulcers and ulcer size larger than the standard 2 cm below the ankle area 4. Mild to moderate neuropathic diabetic foot screening table (UK) 5. 0.50 ˂ Ankle Brachial Index < 0.9 6. HbA1c < 8 7. Non-smoking 8. No signs of wound infection 10. No Having kidney disease(serum creatinine level less than 2 mg / dL ) 11. No Having body fracture occurred recently. 12. No Having skin diseases
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Physiotherapy Department, Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Postal code
Approval date
2013-07-06, 1392/04/15
Ethics committee reference number
D 52.2567

Health conditions studied

1

Description of health condition studied
Diabet Melitus Type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Ankle Brachial Index
Timepoint
session 1 and 12
Method of measurement
Digital Manometer

2

Description
oxygen saturation of peripheral blood
Timepoint
session 1 , 6,12
Method of measurement
Pulse oxymeter

3

Description
Wouns surface area
Timepoint
session 1 , 6,12
Method of measurement
Imaging

4

Description
Nitric Oxide
Timepoint
session 1 and 12
Method of measurement
biochemical analysis

5

Description
HIF-1α
Timepoint
session 1 and 12
Method of measurement
biochemical analysis

6

Description
Vascular Endothelial Growth Factor
Timepoint
session 1 and 12
Method of measurement
biochemical analysis

7

Description
Vascular Endothelial Growth Factor-Receptor 2
Timepoint
session 1 and 12
Method of measurement
biochemical analysis

Secondary outcomes

1

Description
Assessment of physical activity and pain
Timepoint
Start and end of study
Method of measurement
standard Questionnaire SF-36

Intervention groups

1

Description
In Placebo group, Patients will be treated with standard therapy and laser,While it is turned off ,every other day, for 12 sessions.
Category
Treatment - Devices

2

Description
In Laser therapy group,patients will be treated with Ga-As laser, 2 j/cm2, 90 mW and standard therapy, every other day, for 12 sessions.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Dr Manoochehr Iranparvar Alamdari
Street address
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Gity Torkaman
Street address
Physiotherapy Department, Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tabiat Modarres Univercity
Full name of responsible person
Dr Gity Torkaman
Position
Professor
Other areas of specialty/work
Street address
Physiotherapy Department, Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Postal code
Phone
+98 21 8288 4509
Fax
Email
torkamg@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Gity Torkaman
Position
Professor
Other areas of specialty/work
Street address
Physiotherapy Department, Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Postal code
Phone
+98 21 8288 4509
Fax
Email
torkamg@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mahsa Hoseini Sanati
Position
PhD candidate for physical therapy
Other areas of specialty/work
Street address
Physiotherapy Department, Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Postal code
Phone
00
Fax
Email
Mahsa.hoseinisanati@modares.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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