Treatment of Wounds Utilizing Light

Diabetic Ulcer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00634868
• Other study ID #: or003121107
• Status: Terminated
• Phase: N/A
• First received: February 7, 2008
• Last updated: June 9, 2011
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: QRay Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel:Soroka University Medical center Helisinki committeeIsrael:Ministery of health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetic Ulcer

Intervention

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.

Device:
• Qray light therapy device-Sham
non curative light- the device emits the same broad light, but with very low intensity

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Beer Seva

Sponsors (1)

Lead Sponsor	Collaborator
QRay Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The wound healing process		12 weeks	No