Treatment of Wounds Utilizing Light

This study has been terminated.

(Slow patients recruitment)

Sponsor:

Information provided by:

QRay Ltd.

ClinicalTrials.gov Identifier:

NCT00634868

First received: February 7, 2008

Last updated: June 9, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	February 7, 2008
Last Updated Date	June 9, 2011
Start Date ^ICMJE	August 2008
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 12, 2008)	The wound healing process [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00634868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Treatment of Wounds Utilizing Light
Official Title ^ICMJE	Not Provided
Brief Summary	The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Condition ^ICMJE	Diabetic Ulcer
Intervention ^ICMJE	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. Device: Qray light therapy device-Sham non curative light- the device emits the same broad light, but with very low intensity
Study Arm (s)	Sham Comparator: 1 The device is emitting a sham light Intervention: Device: Qray light therapy device-Sham Experimental: 2 The device is emitting curative light Intervention: Other: Qray light therapy device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	30
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient has 8 weeks venus leg ulcer. The ulcer was not better on prior treatment of various medical clinics. The patient has diabetic ulcer grade 1 or 2 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%
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00634868
Other Study ID Numbers ^ICMJE	or003121107
Has Data Monitoring Committee	Yes
Responsible Party	Qray Ltd, Qray
Study Sponsor ^ICMJE	QRay Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	QRay Ltd.
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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