- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00634868
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
-
-
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Beer Seva, Israel
- Soroka Medical Center
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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
|
non curative light- the device emits the same broad light, but with very low intensity
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Experimental: 2
The device is emitting curative light
|
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
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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