IV iloprost may reduce healing time for venous ulcers

General

Clinical Question:
Is intravenous iloprost useful in the treatment of venous leg ulcers?

Bottom Line:
Intravenous iloprost may be useful in the treatment of venous leg ulcers. Further studies comparing iloprost to other standard treatments (eg, Unna boots) are needed. (LOE = 2b)

Reference:
Ferrara F, Meli F, Raimondi F, et al. The treatment of venous leg ulcers. A new therapeutic use of iloprost. Ann Surg 2007;246(5):860-865.  [PMID:17968180]

Study Design:
Randomized controlled trial (single-blinded)

Allocation:
Uncertain

Setting:
Outpatient (specialty)

Synopsis:
The inflammatory process may be causative in persistent venous ulcers. Thus, anti-inflammatories such as iloprost, may be effective in reducing healing times. These investigators enrolled 98 consecutive patients presenting with uncomplicated internal malleolar venous ulcers of the lower limbs. Inclusion criteria were ulcers present less than 18 months, surface area between 10 cm2 and 30 cm2, and chronic venous insufficiency confirmed by ultrasound. Because topical iloprost is ineffective, subjects randomly received (uncertain allocation concealment) intravenous iloprost (starting from 0.5 ng/kg/min progressing up to 2 ng/kg/min for 6 hours per day, 5 days a week for 3 weeks) or matched saline placebo. Local treatment consisted of debridement and application of an elastic bandage. No comparison was made to the more commonly used Unna boot dressing. The authors do not specifically state if the individuals who assessed outcomes were masked to treatment group assignment. However, "complete healing" as an outcome is unlikely to be subjectively determined and potentially biased. Complete follow-up for 150 days occurred for 93% of patients. Using intention-to-treat analysis, after 150 days more ulcers completely healed in the intervention group than in the control group (100% vs 85%; P = .054; difference nonsignificant). There was a statistically significant difference in healing rates at 90 days (treatment group: 100% vs control group: 50%; number needed to treat = 2), so it is likely that ulcers in iloprost-treated patients will heal more quickly.

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