Trials / Completed
CompletedNCT02452086
Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Tarbiat Modarres University · Academic / Other
- Sex
- All
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Accepted
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).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Low Level Laser(Ga-As) | Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2 |
| PROCEDURE | Placebo | LLLT with zero intensity |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2014-11-01
- Completion
- 2015-02-01
- First posted
- 2015-05-22
- Last updated
- 2015-06-01
Locations
1 site across 1 country: Iran
Source: ClinicalTrials.gov record NCT02452086. Inclusion in this directory is not an endorsement.