Treatment of Wounds Utilizing Light

June 9, 2011 updated by: QRay Ltd.
The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Seva, Israel
        • Soroka Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 1
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
Experimental: 2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The wound healing process
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QRay Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 9, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • or003121107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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