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

NCT ID: NCT02452086

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-02-28

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.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Low Level Laser(Ga-As)

Intervention Type: DEVICE

Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

LLLT with zero intensity

Interventions

Low Level Laser(Ga-As)

Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2

Intervention Type: DEVICE

Placebo

LLLT with zero intensity

Intervention Type: PROCEDURE

Other Intervention Names

LLLT; Placebo low level laser therapy

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tarbiat Modarres University

OTHER

Sponsor Role: lead

Responsible Party

giti torkaman

Professor of physical therapy, Physical therapy department, Faculty of medical sciences, Tarbiat modares univercity

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giti Torkaman, PHD

Role: STUDY_DIRECTOR

Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity

Locations

Tarbiat Modares University

Tehran, , Iran

Countries

Iran

References

Torkaman G, Hoseini-Sanati M, Hedayati M, Mofid M, Iranparvar Alamdari M. Effects of Photobiomodulation Therapy on the Expression of Hypoxic Inducible Factor, Vascular Endothelial Growth Factor, and Its Specific Receptor: A Randomized Control Trial in Patients with Diabetic Foot Ulcer. Photobiomodul Photomed Laser Surg. 2024 Apr;42(4):275-284. doi: 10.1089/photob.2023.0152. Epub 2024 Mar 27.

Reference Type: DERIVED

PMID: 38536106 (View on PubMed)

Other Identifiers

D52.2567

Identifier Type: -

Identifier Source: org_study_id