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Clinical Trial Summary

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).


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02452086
Study type Interventional
Source Tarbiat Modarres University
Contact
Status Completed
Phase N/A
Start date June 2013
Completion date February 2015

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