Treatment of Wounds Utilizing Light

QRay

Status: Terminated

Conditions: Diabetic Ulcer

Treatments: Other: Qray light therapy device; Device: Qray light therapy device-Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT00634868

or003121107

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

1

Sham Comparator group

Description:

The device is emitting a sham light

Treatment:

Device: Qray light therapy device-Sham

2

Experimental group

Description:

The device is emitting curative light

Treatment:

Other: Qray light therapy device