A prospective, randomized trial of Unna's boot versus Duoderm CGF hydroactive dressing plus compression in the management of venous leg ulcers

Abstract

Leg ulcers caused by chronic venous insufficiency plague an estimated 500,000 Americans, but there have been few improvements in conservative treatment in this century, and Unna's boot continues to be a mainstay of therapy. A recent report suggests that Duoderm CGF dressing provides greater patient comfort and enhanced compliance, but Duoderm alone (without compression) resulted in slower healing compared with Unna's boot. We enrolled 30 patients (30 ulcers) in a clinical trial to compare Duoderm CGF plus compression (Coban wrap) to Unna's boot. No significant difference was observed between the two groups with respect to age, sex, initial ulcer area, ulcer duration, or extent of venous insufficiency by duplex scan. Eight of 16 ulcers (50%) in the Duoderm group healed completely versus 6 of 14 ulcers (43%) in the Unna's boot group (p = 0.18). Healing rates (square centimeters per week) correlated significantly with initial ulcer area and initial ulcer perimeter for both groups but best correlated with initial ulcer perimeter (r = 0.88 with Duoderm, p < 0.0001; r = 0.80 with Unna's boot, p < 0.002). After adjusting for differences in initial ulcer perimeter, healing rates were significantly faster for patients on Duoderm than patients on Unna's boot during the first 4 weeks of therapy (0.384 ± 0.059 cm2/wk/cm perimeter for Duoderm versus 0.135 ± 0.043 cm2/wk/cm perimeter for Unna's boot; p = 0.002). At 12 weeks patients on Duoderm again appeared to heal faster than those on Unna's boot, although the result did not reach statistical significance (0.049 ± 0.007 cm2/wk/cm perimeter for Duoderm versus 0.020 ± 0.017 for Unna's boot, p = 0.11). In conclusion, in patients with well-documented venous stasis ulcers, Duoderm CGF HD treatment with compression resulted in ulcer healing rates that were faster than Unna's boot during initial therapy and may be faster over a 12-week treatment period.