A prospective, randomized, double-blind, placebo-controlled multicentre study assessed the clinical efficacy and safety of pulsed electromagnetic limb ulcer therapy (PELUT) in the healing of recalcitrant, predominantly venous leg ulcers. The portable device was used at home for 3 h daily during this 8-week clinical trial as an adjunct to a wound dressing. Wound surface area, ulcer depth and pain intensity were assessed at weeks 0, 4 and 8. At week 8 the active group had a 47.7% decrease in wound surface area vs. a 42.3% increase for placebo (P < 0.0002). Investigators' global evaluations indicated that 50% of the ulcers in the active group healed or markedly improved vs. 0% in the placebo group, and 0% of the active group worsened vs. 54% of the placebo group (P < 0.001). Significant decreases in wound depth (P < 0.04) and pain intensity (P < 0.04) favouring the active group were seen. Patients whose ulcers improved significantly after 8 weeks were permitted to continue double-blind therapy for an additional 4 weeks. Eleven active and one placebo patient continued therapy until week 12, with the active treatment group continuing to show improvement. There were no reports of adverse events attributable to this device. We conclude that the PELUT device is a safe and effective adjunct to non-surgical therapy for recalcitrant venous leg ulcers.
We report the results of a 2-week double-blind, parallel clinical trial comparing two superpotent topical glucocorticosteroid ointments, diflorasone diacetate 0.05% and betamethasone dipropionate 0.05%, in psoriatic adults. Both corticosteroid ointments were fast acting and highly efficacious. 40 of the 44 patients who initially enrolled completed the trial. There were no statistically significant differences between the two glucocorticoids with respect to erythema, scaling, induration or the investigator’s global evaluation after either 1 or 2 weeks of therapy. The level of patient satisfaction with the efficacy and cosmetic acceptability of these two category I glucocorticoids was similar. No systemic or local adverse reactions were noted.
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