For the first time efficacy and safety of a new prostaglandin E1 (PGE1) regimen in the treatment of intermittent claudication were evaluated in a randomized, double-blind, placebo-controlled multicenter clinical trial. The study involved 213 outpatients with a maximum walking distance of 50 to 200 m measured on the treadmill (3 km/hr, 12% grade). After a 2-week run-in phase they received a 2-hour intravenous infusion of 60 micrograms PGE1 or placebo 5 days a week for 4 weeks. It was followed by a 4-week interval treatment with the same medication administered only twice a week. Patients were monitored for 3 months when they received no study medication. In the PGE1 group the intention-to-treat analysis (n = 208) revealed an increase in walking distance after 4 weeks of 75% (placebo, 43%). At the end of the interval treatment the walking distance had improved to 101% (placebo, 60%). The results remained virtually constant during follow-up (PGE1, 104%, placebo, 63%). Between-group comparisons showed significant differences in favor of PGE1 for all three time points of measurement (p < 0.05, p < 0.01, and p < 0.05). PGE1 was well tolerated; the rate of adverse reactions related to the treatment was 12.8% (placebo, 7.7%). In summary, these results show that the new PGE1 regimen is effective and safe in the treatment of outpatients with intermittent claudication.

Hospitalisation rate for major amputation in Germany decreased in the recent years whereas hospitalisation rate for minor amputation did not.

ZusammenfassungUlcera der unteren Extremität und des Fußes sind in etwa 90 % der Fälle vaskulärer Genese. Nur 10 % der Ulcera haben andere, seltene Ursachen. Nach einem schweren Trauma mit Deformierung und Fehlstellung des Fußes in 90-Grad Außenrotation kam es bei einer heute 77-jährigen Patientin zur Ausbildung therapieresistenter Ulcera cruris et pedis. Durch eine Shave-Therapie mit simultaner Meshgraft-Plastik und intensiver Nachbehandlung des sekundären Lymphödems konnte eine komplette Heilung erzielt werden.

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