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

Tarbiat Modarres University

Status: Completed

Conditions: Diabetic Foot Ulcer

Treatments: Procedure: Placebo; Device: Low Level Laser(Ga-As)

Study type: Interventional

Funder types: Other

Identifiers

NCT02452086

D52.2567

Details and patient eligibility

About

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).

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups, including a placebo group

Low Level Laser Therapy

Active Comparator group

Description:

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)

Treatment:

Device: Low Level Laser(Ga-As)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Procedure: Placebo