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

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Low Level Laser(Ga-As)
Placebo
Sponsored by
Tarbiat Modarres University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Tarbiat Modares University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Low Level Laser Therapy

Placebo

Arm 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)

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

Outcomes

Primary Outcome Measures

The blood serum level of VEGF(pg/ml), VEGFR-2(pg/ml), HIF-1α(pg/ml) and NO (pg/ml)
measured from serum in initial and end sessions.

Secondary Outcome Measures

Wound surface area(cm2)
Oxygen saturation of peripheral blood
Ankle Brachial Index(ABI)

Full Information

First Posted
May 10, 2015
Last Updated
May 29, 2015
Sponsor
Tarbiat Modarres University
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1. Study Identification

Unique Protocol Identification Number
NCT02452086
Brief Title
Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tarbiat Modarres University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Level Laser Therapy
Arm Type
Active Comparator
Arm 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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Low Level Laser(Ga-As)
Other Intervention Name(s)
LLLT
Intervention Description
Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2
Intervention Type
Procedure
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo low level laser therapy
Intervention Description
LLLT with zero intensity
Primary Outcome Measure Information:
Title
The blood serum level of VEGF(pg/ml), VEGFR-2(pg/ml), HIF-1α(pg/ml) and NO (pg/ml)
Description
measured from serum in initial and end sessions.
Time Frame
Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
Secondary Outcome Measure Information:
Title
Wound surface area(cm2)
Time Frame
Change from Baseline in wound surface area at 2 and 4 weeks
Title
Oxygen saturation of peripheral blood
Time Frame
Change from Baseline with pulse oximeter at 2 and 4 weeks
Title
Ankle Brachial Index(ABI)
Time Frame
Change from Baselineat 2 and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giti Torkaman, PHD
Organizational Affiliation
Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity
Official's Role
Study Director
Facility Information:
Facility Name
Tarbiat Modares University
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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