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A randomized clinical trial on the effect of low-level laser therapy on chronic diabetic foot wound healing: a preliminary report |
Kaviani A, Djavid GE, Ataie-Fashtami L, Fateh M, Ghodsi M, Salami M, Zand N, Kashef N, Larijani B |
Photomedicine and Laser Surgery 2011 Feb;29(2):109-114 |
clinical trial |
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; 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: Low-level laser therapy (LLLT) has been shown to promote chronic wound healing in conditions of reduced microcirculation. In this preliminary study, we report the results of using LLLT to heal foot ulcers in patients with diabetes mellitus. MATERIALS AND METHODS: Twenty-three patients with a diabetic foot wound for at least 3 months were included in this double-blind randomized clinical trial. Patients were randomized to receive placebo treatment (n = 10) or LLLT (n = 13) (685 nm, energy density 10 J/cm2) in addition to conventional therapy. Patients were followed for 20 weeks. Ulcer size reduction and the number of patients with complete healing were compared between the LLLT and placebo groups. RESULTS: There were no significant differences in baseline characteristics of patients and foot ulcers receiving LLLT and placebo treatment. At week 4, the size of ulcers decreased significantly in the LLLT group (p = 0.04). After 20 weeks, in the LLLT group, eight patients had complete healing and in the placebo group only three patients experienced complete wound healing. The mean time of complete healing in LLLT patients (11 weeks) was less than that in placebo patients (14 weeks) though the difference was not statistically significant. CONCLUSIONS: The study provides evidence that LLLT can accelerate the healing process of chronic diabetic foot ulcers, and it can be presumed that LLLT may shorten the time period needed to achieve complete healing.
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