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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

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
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634868

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

No publications provided

Responsible Party: Qray Ltd, Qray
ClinicalTrials.gov Identifier: NCT00634868     History of Changes
Other Study ID Numbers: or003121107
Study First Received: February 7, 2008
Last Updated: June 9, 2011
Health Authority: Israel:Soroka University Medical center Helisinki committee
Israel:Ministery of health

Keywords provided by QRay Ltd.:
ulcer wound diabetes

Additional relevant MeSH terms:
Ulcer
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014