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

May 29, 2015 updated by: giti torkaman, Tarbiat Modarres University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Low Level Laser Therapy

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)
Device: Low Level Laser(Ga-As)
Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2
Other Names:
  • LLLT
PLACEBO_COMPARATOR: 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
Procedure: Placebo
LLLT with zero intensity
Other Names:
  • Placebo low level laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The blood serum level of VEGF(pg/ml), VEGFR-2(pg/ml), HIF-1α(pg/ml) and NO (pg/ml)
Time Frame: 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.
Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tarbiat Modarres University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

May 10, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (ESTIMATE)

May 22, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D52.2567

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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