Average percentage reduction of ulcer area is the study's primary end-point. If data are normally distributed (determined by probit or logit plot) statistical analysis can be performed using Student's t-test. Non-normally distributed data can be analyzed using transformation of data or non-parametric statistics (Wilcoxon rank sum test or Mann-Whitney U-test). Other numerical data (cutaneous oxygen tension, pain scoring, use of analgesics) can be statistically evaluated in the same manner as ulcer area reduction.