Diabetic UlcerNCT00634868
Treatment of Wounds Utilizing Light
A study testing Qray light therapy device in people with Diabetic Ulcer, run by QRay Ltd. at 1 site in Israel.
Trial summary
The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Ulcer
- What is being tested?
- Qray light therapy device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded.
- Conditions
- Diabetic Ulcer
- Being tested
- Qray light therapy device, Qray light therapy device-Sham
- Keywords
- ulcer wound diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qray light therapy deviceOther
The light is filtered from harmful UV and InfraRed light and only light at wavelight of 405nm until 1000nm is delivered.
Qray light therapy device-ShamDevice
non curative light- the device emits the same broad light, but with very low intensity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | The device is emitting a sham light Receives: Device: Qray light therapy device-Sham |
| 2 | Experimental | The device is emitting curative light Receives: Other: Qray light therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The wound healing process
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Slow patients recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QRay Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634868
- Sponsor's protocol ID
- or003121107
- Status last verified
- Jun 2011
- First submitted
- 7 Feb 2008
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Wounds Utilizing Light
- ClinicalTrials.gov ID
- NCT00634868
- Acronym / sponsor ID
- or003121107
- Conditions
- Diabetic Ulcer
- Keywords
- ulcer wound diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow patients recruitment
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- QRay Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Device: Qray light therapy device-ShamThe device is emitting a sham light |
| 2 | Experimental | Other: Qray light therapy deviceThe device is emitting curative light |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qray light therapy deviceThe light is filtered from harmful UV and InfraRed light and only light at wavelight of 405nm until 1000nm is delivered. | Other | 2 |
| Qray light therapy device-Shamnon curative light- the device emits the same broad light, but with very low intensity | Device | 1 |
Primary outcome
The wound healing process
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Slow patients recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qray light therapy device in people with Diabetic Ulcer, run by QRay Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow patients recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The wound healing process (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.