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RESEARCH PRODUCT
Efficacy of the treatment with prostaglandin E-1 in venous ulcers of the lower limbs.
Piero Luigi AlmasioSalvatore NovoChiara MinàValentina CospiteGlauco Miliosubject
AdultMalemedicine.medical_specialtymedicine.medical_treatmentVasodilator AgentsIschemiaHealing timeProstaglandinPlacebolaw.inventionVaricose Ulcerchemistry.chemical_compoundRandomized controlled triallawMedicineHumansSingle-Blind MethodAlprostadilAgedLegUltrasonography Doppler DuplexWound Healingbusiness.industryMiddle Agedmedicine.diseasedigestive system diseasesSurgeryClinical trialchemistryBaseline characteristicsVenous ulcers Prostaglandine E-1SurgeryFemaleCardiology and Cardiovascular MedicinebusinessProstaglandin Edescription
Background. Venous ulcers represent an important medical problem due to their high prevalence and consequent sanitary costs. In this study we evaluated the effect of Prostaglandin E-1 (PGE-1), a drug that improves district ischemia, on the healing of venous ulcers. Methods. We performed a randomized, placebo-controlled, single blind study, in which 87 patients, carriers of venous leg ulcers, homogeneous for dimensions and characteristics, were treated for 20 days an with infusion of Prostaglandin E-1 or placebo, in association with a topic therapy. The dimension and the number of the ulcers were determined at the beginning of the treatment and then every 20 days up to 4 months or until total recovery. The main outcome of the study was the recovery percentage of the ulcers at the end of the period of observation (120 days) and the referred healing time. The reduction in the extension of ulcers from the baseline measurement to the last observation was also evaluated. Results. The baseline characteristics in the two groups were similar. The reduction in the size of the ulcers was faster in the group of patients treated with PGE-1. In this group 100% of the ulcers healed after 100 days, while in the placebo group only 84.2% did so by the end of the observation period (120 days) (P <. 05). The estimated healing times of 25%, 50% and 75% of the patients treated with PGE-1 were 23, 49 and 72 days respectively, versus 52, 80 and 108 for the patients in the placebo group. Only one serious event occurred in the treated group. Conclusions: The results of this study demonstrate the effectiveness of PGE-1 in reducing the healing time of venous ulcers suggesting that venous ulcers should also be considered ischaemic.
year | journal | country | edition | language |
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2005-08-01 | Journal of vascular surgery |