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

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Low Level Laser(Ga-As); Procedure: Placebo

• Registration Number: NCT02452086
• Lead Sponsor: Tarbiat Modarres University

Brief 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.

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-11
• Study Completion: 2015-02
• Status Verified: 2015-05
• Study First Submitted: 2015-05-10
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-22
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Level Laser Therapy	Low Level Laser(Ga-As)	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)
Placebo	Placebo	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Wound surface area(cm2)	Change from Baseline in wound surface area at 2 and 4 weeks
Ankle Brachial Index(ABI)	Change from Baselineat 2 and 4 weeks
Oxygen saturation of peripheral blood	Change from Baseline with pulse oximeter at 2 and 4 weeks

Trial Locations

Locations (1)

Tarbiat Modares University; 🇮🇷 Tehran, Iran, Islamic Republic of