Table 3

Secondary end points—intention-to-treat analysis

	Sildenafil N=42	Placebo N=41	p Value
Number of DUs per patient
W0	2.1±1.4	2.5±2.1	0.24*
W4	1.5±1.2	1.9±2.0	0.22*
W8	1.2±1.6	1.8±2.4	0.04*
W12	0.9±1.6	1.5±2.7	0.01*
Patients with complete healing of DUs that were present at entry
W12	26 (70.3%)	23 (60.5%)	0.45*
Patients with no DUs at W12 (N; %)
W12	25 (67.6%)	18 (48.7%)	0.10*
Patients with ≥1 new DU having occurred between W4 and W12 (N; %)
	8 (21.6%)	15 (39.5%)	0.10*

Results are expressed as mean±SD or N (%). Continuous variables are compared between groups with Student's t test, χ² test or Fisher's exact test.
*χ² test comparing the distribution of the three categories between the two groups.
DU, digital ulcer; W, week.