The use of low energy photon therapy (LEPT) in venous leg ulcers: a double-blind, placebo-controlled study.

BACKGROUND

Venous ulcers are estimated to be present in 0.2 to 0.4% of the population. Although new therapies have significant promise, nonhealing ulcers still represent a significant problem.

OBJECTIVE

To evaluate the efficacy of low energy photon therapy (LEPT) in the treatment of venous leg ulcers.

METHODS

A placebo-controlled, double-blind study using low energy photon therapy was performed in nine patients with 12 venous ulcers. Treatment was given three times a week for 10 weeks, using two monochromatic optical sources. One source provided a wavelength (lambda) of 660 nm (red) while the second source delivered a wavelength of 880 nm (infrared). Two optical probes were used, one consisted of an array of 22 monochromatic sources, operating at a wavelength of 660 nm and covering an area 6 x 10 cm2. The second probe had seven infrared sources, operating at a wavelength of 880 nm and covering an area of 4 cm2. The above configuration of optical probes was selected to cover the majority of the ulcer area being treated. The patients who were randomized to placebo treatment received sham therapy from an identical-appearing light source from the same delivery system.

RESULTS

Nine patients with 12 venous ulcers were randomized to receive LEPT or placebo therapy. At the conclusion of the study, the percentage of the initial ulcer area remaining unhealed in the LEPT and placebo groups was 24.4% and 84.7%, respectively (P = 0.0008). The decrease in ulcer area (compared to baseline) observed in the LEPT and placebo groups was 193.0 mm2 and 14.7 mm2, respectively (P = 0.0002). One patient dropped out of the study, complaining of lack of treatment efficacy; he was found to be randomized to the placebo group. There were no adverse effects.

CONCLUSION

In this placebo-controlled, double-blind study LEPT was an effective modality for the treatment of venous leg ulcers.