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Treatment of Wounds Utilizing Light

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ClinicalTrials.gov Identifier: NCT00634868
Recruitment Status : Terminated (Slow patients recruitment)
First Posted : March 13, 2008
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
QRay Ltd.

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

Condition or disease Intervention/treatment Phase
Diabetic Ulcer Other: Qray light therapy device Device: Qray light therapy device-Sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : August 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


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.




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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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%

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.

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

Keywords provided by QRay Ltd.:
ulcer wound diabetes