Treatment of Wounds Utilizing Light

NCT ID: NCT00634868

Last Updated: 2011-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetic Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

The device is emitting a sham light

Group Type SHAM_COMPARATOR

Qray light therapy device-Sham

Intervention Type DEVICE

non curative light- the device emits the same broad light, but with very low intensity

2

The device is emitting curative light

Group Type EXPERIMENTAL

Qray light therapy device

Intervention Type OTHER

The light is filtered from harmful UV and InfraRed light and only light at wavelight of 405nm until 1000nm is delivered.

Interventions

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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.

Intervention Type OTHER

Qray light therapy device-Sham

non curative light- the device emits the same broad light, but with very low intensity

Intervention Type DEVICE

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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QRay Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Qray

Locations

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Soroka Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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or003121107

Identifier Type: -

Identifier Source: org_study_id

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