Background: Venous ulcers can be difficult to heal, and prognostic factors
for healing have not been fully elucidated.
Objective: The objective of this study was to analyze the results of a larg
e multicenter venous deer trial to retrospectively establish prognostic fac
tors for venous ulcer healing.
Methods: This study examined data from a previously published prospective r
andomized placebo-controlled trial of an oral medication versus placebo tre
atment for venous ulcers. Local leg ulcer care involved the use of a moistu
re-retentive dressing and sustained graduated compression with a paste band
age and a self-adherent wrap. The oral medication or placebo was administer
ed on a daily basis with the same dressings and bandage system in both grou
ps for 12 weeks. A total of 165 patients completed the full 12-week treatme
nt period; 83 received ifetroban, 82 received placebo.
Results: There was no statistically significant difference in outcome betwe
en the two groups. The study showed that consistent local ulcer treatment w
ith a clearly defined system of care was associated with an unexpectedly hi
gh percentage (55%) of long-standing large venous ulcers (mean duration, 27
months; mean area, 15.9 cm(2)) being healed in both groups. Baseline ulcer
area and duration of leg ulcer were found to be important in predicting ou
tcome. Ulcers of short duration were found to be most,likely to heal. Perce
nt healing and ulcer area at week 3 were good predictors of 100% healing. U
lcers that had at least 40% healing by week 3 predicted more than 70% of th
e outcomes correctly
Conclusion: From this large study it was determined that baseline ulcer are
a and ulcer duration are significant predictors of 100% healing and time to
heal. Percent healing and ulcer area at week 3 are good predictors of comp
lete ulcer healing. Ulcers that are large, long-standing and slow to heal a
fter 3 weeks of optimal therapy are unlikely to heal rapidly, and might ben
efit from alternative therapies.