Research Study Summary
A clinical trial to evaluate treatments using Monochromatic phototherapy, Biolight® and Monochromatic phototherapy for patients with Diabetic Foot Ulcers
Research Study Title
Monochromatic Phototherapy on Diabetic Foot Ulcers. A Twenty Weeks Prospective, Randomised, Double Blind, Multi-centre, Placebo Controlled Study
The purpose of this study is to evaluate the efficacy and safety of monochromatic
phototherapy (Biolight®) on foot ulcers in diabetic patients, in comparison of placebo
phototherapy as a complementary to standard diabetic foot ulcer therapy.
The study initiated with a four week long Run In Period to eliminate spontaneous healing
ulcer to be included. Treatment with monochromatic phototherapy (Biolight® or placebo) will
be given locally, additional to standard care, three times weekly during the first four
weeks and twice weekly the following sixteen weeks or until the ulcer is completely healed,
according to a pre-determined treatment plan. The area of the ulcer will be measured once
weekly for 20 weeks or until the ulcer is completely healed.
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