NCT02452086

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

1.4 years

First QC Date

May 10, 2015

Last Update Submit

May 29, 2015

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks

Secondary Outcomes (3)

  • Wound surface area(cm2)

    Change from Baseline in wound surface area at 2 and 4 weeks

  • Oxygen saturation of peripheral blood

    Change from Baseline with pulse oximeter at 2 and 4 weeks

  • Ankle Brachial Index(ABI)

    Change from Baselineat 2 and 4 weeks

Study Arms (2)

Low Level Laser Therapy

ACTIVE COMPARATOR

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)

Placebo

PLACEBO COMPARATOR

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

Interventions

Low Level Laser(Ga-As)DEVICE

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

Also known as: LLLT
Low Level Laser Therapy
PlaceboPROCEDURE

LLLT with zero intensity

Also known as: Placebo low level laser therapy
Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic diabetic foot ulcer
  • Wagner classification DFU 2
  • \<ABI\<0.9
  • Mild to moderate diabetic neuropathy

You may not qualify if:

  • Fracture in a lower limb
  • A severe infection
  • A malignancy
  • Kidney failure
  • Skin diseases
  • Osteomyelitis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarbiat Modares University

Tehran, Iran

Location

Related Publications (1)

  • 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.

    PMID: 38536106DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Giti Torkaman, PHD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of physical therapy, Physical therapy department, Faculty of medical sciences, Tarbiat modares univercity

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 22, 2015

Study Start

June 1, 2013

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

IR(1)