NCT00634868

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

2.3 years

First QC Date

February 7, 2008

Last Update Submit

June 9, 2011

Conditions

Diabetic Ulcer

Keywords

ulcer wound diabetes

Outcome Measures

Primary Outcomes (1)

  • The wound healing process

    12 weeks

Study Arms (2)

1

SHAM COMPARATOR

The device is emitting a sham light

Device: Qray light therapy device-Sham

2

EXPERIMENTAL

The device is emitting curative light

Other: Qray light therapy device

Interventions

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.

2
Qray light therapy device-ShamDEVICE

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

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 7, 2008

First Posted

March 13, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

IL(1)