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
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, see Learn About Clinical Studies.

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 August 20, 2014