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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452086
• Other study ID #: D52.2567
• Status: Completed
• Phase: N/A
• First received: May 10, 2015
• Last updated: May 29, 2015
• Start date: June 2013
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: Tarbiat Modarres University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• Low Level Laser(Ga-As)
Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2

Procedure:
• Placebo
LLLT with zero intensity

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tarbiat Modares University	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tarbiat Modarres University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The blood serum level of VEGF(pg/ml), VEGFR-2(pg/ml), HIF-1a(pg/ml) and NO (pg/ml)	measured from serum in initial and end sessions.	Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1a and NO at 4 weeks	No
Secondary	Wound surface area(cm2)		Change from Baseline in wound surface area at 2 and 4 weeks	No
Secondary	Oxygen saturation of peripheral blood		Change from Baseline with pulse oximeter at 2 and 4 weeks	No
Secondary	Ankle Brachial Index(ABI)		Change from Baselineat 2 and 4 weeks	No