Purpose: Lower extremity infections in the presence vascular insufficiency are difficult and costly to treat. Few well-controlled clinical trials evaluating the management of these infections exist. We decided to investigate the ability of a new fluoroquinolone, ciprofloxacin, to reduce the morbidity associated with these infections and the amount of in-hospital time required for the administration of antibiotic therapy.
Patients and methods: Forty-eight patients with peripheral vascular disease (46 with diabetes mellitus) who presented to the hospital for treatment of lower extremity infections were randomized in a blinded fashion to receive oral ciprofloxacin at a dosage of either 750 mg or 1,000 mg twice daily. Patients with osteomyelitis received three months of therapy and those with infections limited to soft tissues, three weeks of ciprofloxacin treatment. All subjects were followed for one year.
Results: One patient received an amputation 24 hours after enrollment, and two patients discontinued therapy after 20 and 34 days because of adverse effects and were not evaluable. At the one-year follow-up, 27 of the 45 (60 percent) evaluable patients had a fully successful outcome defined as not requiring either repeat antimicrobial therapy for their initial infection or amputation of the involved extremity. In the group of 18 patients in whom therapy failed, a total of only nine amputations were required. In the 15 patients whose lesion closed during therapy, 93% (14 patients) experienced a long-term successful outcome.
Conclusion: Treatment with this new fluoroquinolone offers promise for the improved outcome of patients with the serious infectious complication of infected lower extremity ulcerations in peripheral vascular disease, diabetes mellitus, or both.