Treatment of Wounds Utilizing Light

This study is currently recruiting participants.

Verified by QRay Ltd., January 2009

First Received: February 7, 2008 Last Updated: January 11, 2009 History of Changes

Sponsored by:	QRay Ltd.
Information provided by:	QRay Ltd.
ClinicalTrials.gov Identifier:	NCT00634868

Purpose

The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded.

Condition	Intervention
Diabetic Ulcer	Other: Qray light therapy device Device: Qray light therapy device-Sham

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by QRay Ltd.:

Primary Outcome Measures:

The wound healing process [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Sham Comparator The device is emitting a sham light	Device: Qray light therapy device-Sham non curative light- the device emits the same broad light, but with very low intensity
2: Experimental The device is emitting curative light	Other: Qray light therapy device The light is filtered from harmful UV and InfraRed light and only light at wavelight of 405nm until 1000nm is delivered.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Patient has severe infection.
Patient is taking antibiotic
Patient has ankle brachial index less than 0.7
Patient is schedule to undergone revascularization surgery 10 weeks before the study
Patient has photosensitive disease
Patient has cancer
Creatinine level is more than 2 mg%
Patient is taking immunosuppressive medication.
Pregnant women
Dialysis patient
Anaemic patients(less than 9 gr)
Patient has Albumin level less than 3 mg%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634868

Locations

Israel
Soroka Medical Center	Recruiting
Beer Seva, Israel
Contact: Ilana Harman, MD 0522703668 ilanahb@bgu.ac.il
Principal Investigator: Ilana Harman, MD

Sponsors and Collaborators

QRay Ltd.

More Information

No publications provided

Responsible Party:	Qray ( Qray Ltd )
Study ID Numbers:	or003121107
Study First Received:	February 7, 2008
Last Updated:	January 11, 2009
ClinicalTrials.gov Identifier:	NCT00634868 History of Changes
Health Authority:	Israel:Soroka University Medical center Helisinki committee; Israel:Ministery of health

Keywords provided by QRay Ltd.:

ulcer wound diabetes

Study placed in the following topic categories:

Ulcer
Diabetes Mellitus

ClinicalTrials.gov processed this record on September 10, 2009