Diabetic Foot Ulcer Clinical Trial
Official title:
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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