Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The purpose of this study is to examine the changes of factors including Vascular Endothelial Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area and ankle-brachial index (ABI) in ischemic diabetic foot ulcers after Low Level Laser Therapy(LLLT).

Detailed Description
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Defects in vessels and neovascularization makes diabetic chronic wounds difficult to treat, A decrease of angiogenic factor expression such as Vascular Endothelial Growth Factor(VEGF) and its receptors is involved in angiogenesis inhibition in diabetic ulcers. LLLT as a therapeutic treatment modality can effect on release of these factors and angiogenesis in wound site. The purpose of this study is to examine the changes of factors including VEGF, VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area in ischemic diabetic foot ulcers after LLLT, Therefore, the investigators can evaluate molecular process of angiogenesis, as a mechanism of useful effects of LLLT. In order to patients with ischemic diabetic foot ulcers(DFU) assigned into LLLT with Ga-As(904 nm) laser and placebo groups and will be treated for 12 sessions, every other day. On the first and last (twelfth) 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. Wound surface area and oxygen saturation of peripheral blood and ankle-brachial index (ABI) are measured at first and twelfth treatment.

Official Title
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Effect of Low Level Laser With Ga-As (904 nm) on Expression of Angiogenic Factors (VEGF, VEGF Receptor-2,NO, HIF-1α), Oxygen Saturation of Peripheral Blood and Wound Surface Area in Ischemic Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: Low Level Laser(Ga-As)
* Procedure: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic diabetic foot ulcer Wagner classification DFU 2 0.5<ABI<0.9 Mild to moderate diabetic neuropathy Exclusion Criteria: Fracture in a lower limb A severe infection A malignancy Kidney failure Skin diseases Osteomyelitis Pregnancy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Level Laser Therapy<br>In laser therapy group, group who received interventions was the patients received laser with 2 Joule/centimeters2, 90 milliwatt , 3 days/week, for 4 weeks (12 sessions) | Device: Low Level Laser(Ga-As)<br>* Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2<br>* Other names: LLLT;|
| Placebo Comparator: Placebo<br>In the placebo group, the treatment procedure was the same as that the LLLT group, but the laser light was off and Guiding light was laser was on | Procedure: Placebo<br>* LLLT with zero intensity<br>* Other names: Placebo low level laser therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The blood serum level of VEGF(pg/ml), VEGFR-2(pg/ml), HIF-1α(pg/ml) and NO (pg/ml) | measured from serum in initial and end sessions. | Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound surface area(cm2) |  | Change from Baseline in wound surface area at 2 and 4 weeks | 
| Oxygen saturation of peripheral blood |  | Change from Baseline with pulse oximeter at 2 and 4 weeks | 
| Ankle Brachial Index(ABI) |  | Change from Baselineat 2 and 4 weeks |