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Visible light-induced healing of diabetic or venous foot ulcers: a placebo-controlled double-blind study |
Landau Z, Migdal M, Lipovsky A, Lubart R |
Photomedicine and Laser Surgery 2011 Jun;29(6):399-404 |
clinical trial |
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND AND OBJECTIVES: Non-healing ulcers represent a significant dermatological problem. Recently, conventional therapy-resistant chronic ulcers have been treated with low energy lasers or light-emitting diodes in the visible and near IR region, but only a few placebo-controlled double-blind studies have been performed to support the efficacy of this approach. The aim of the present study was to evaluate the efficacy of a broadband (400 to 800 nm) visible light device in the treatment of leg or foot ulcers. METHODS: A placebo-controlled double-blind study using broadband light source (400 to 800 nm) was performed on patients with diabetic foot ulcers or patients with chronic leg ulcers. The treatment group was illuminated with 180 mW/cm2 broadband light twice a day for 4 min/session, while patients in the placebo group received non-healing light fluency (10 mW/cm2) projections. The treatment group included 10 patients with a total of 19 ulcers, whereas in the placebo group, 6 patients had 6 ulcers. The follow-up period was 12 weeks. RESULTS: At the end of the follow up, all the wounds were closed in 9 out of 10 patients (90%) from the treatment group, whereas in the placebo group only 2 out of 6 patients exhibited closed wounds (33%). The reduction in wound size in the treatment group versus the placebo group was 89% and 54%, respectively. CONCLUSIONS: In this small scale placebo-controlled double-blind study, broadband (400 to 800 nm) visible light was an effective modality for the treatment of leg or foot ulcers.
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