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Treatment of Wounds Utilizing Light

This study has been terminated.
(Slow patients recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00634868
First Posted: March 13, 2008
Last Update Posted: June 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
QRay Ltd.
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by QRay Ltd.:

Primary Outcome Measures:
  • The wound healing process [ Time Frame: 12 weeks ]

Estimated Enrollment: 30
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634868


Locations
Israel
Soroka Medical Center
Beer Seva, Israel
Sponsors and Collaborators
QRay Ltd.
  More Information

Responsible Party: Qray Ltd, Qray
ClinicalTrials.gov Identifier: NCT00634868     History of Changes
Other Study ID Numbers: or003121107
First Submitted: February 7, 2008
First Posted: March 13, 2008
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by QRay Ltd.:
ulcer wound diabetes