Treatment of Wounds Utilizing Light

Not Applicable

Terminated

• Conditions: Diabetic Ulcer
• Interventions: Device: Qray light therapy device-Sham; Other: Qray light therapy device

• Registration Number: NCT00634868
• Lead Sponsor: QRay Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Study Start: 2008-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-09
• Last Update Posted: 2011-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Qray light therapy device-Sham	The device is emitting a sham light
2	Qray light therapy device	The device is emitting curative light

Primary Outcome Measures

Name	Time	Method
The wound healing process	12 weeks

Trial Locations

Locations (1)

Soroka Medical Center; 🇮🇱 Beer Seva, Israel