Diabetic Ulcer
Conditions
Keywords
ulcer wound diabetes
Brief summary
The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded.
Interventions
OTHERQray light therapy device
The light is filtered from harmful UV and InfraRed light and only light at wavelight of 405nm until 1000nm is delivered.
DEVICEQray light therapy device-Sham
non curative light- the device emits the same broad light, but with very low intensity
Sponsors
QRay Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The wound healing process | 12 weeks |
Countries
Israel
Outcome results
None listed