Table 4.

Primary, secondary and safety study outcomes

	Cohort	Conventional group	Orthèse Diabète	P value
Primary outcome
Blinded assessment of wound closure of the index plantar ulcer at the 3-month visit*	ITT	19 (33)	19 (35)	0.79
Blinded assessment of wound closure of the index plantar ulcer at the 3-month visit	PP	18 (34)	17 (37)	0.76
Secondary outcomes
Closure of the index plantar ulcer
1-month visit	ITT	4 (7)	9 (17)	0.11
2-month visit	ITT	15 (26)	17 (31)	0.51
6-month visit	ITT	28 (48)	31 (57)	0.33
Closure of all initial plantar ulcers
1-month visit	ITT	4 (7)	8 (15)	0.19
2-month visit	ITT	12 (21)	13 (24)	0.82
3-month visit	ITT	17 (30)	18 (33)	0.84
6-month visit	ITT	24 (42)	23 (43)	0.96
Relative area reduction of the index plantar ulcer (%)
1-month visit	ITT	63 (52 to 74)	58 (47 to 70)	0.56
2-month visit	ITT	76 (67 to 85)	77 (68 to 87)	0.88
3-month visit	ITT	85 (76 to 94)	85 (76 to 94)	0.96
6-month visit	ITT	87 (79 to 94)	92 (85 to 99)	0.33
Estimated time to reach closure of the index plantar ulcer (days)	ITT	81 (61 to 102)	85 (66 to 103)	0.80
New plantar ulcer	ITT	14 (25)	14 (27)	0.82
Ipsilateral limb-amputation	ITT	2 (4)	5 (10)	0.20
Infectious complication	ITT	8 (14)	7 (13)	0.68
Safety
Any adverse events	Safety	16 (28)	19 (28)	0.97
Any serious adverse events	Safety	41 (72)	48 (72)	0.97
Any adverse events related to offloading device	Safety	2 (4)	10 (15)	0.03
Adverse events leading to discontinuation	Safety	0	3 (4)	0.11
All-cause hospitalization	Safety	23 (40)	18 (27)	0.11
Death	Safety	1 (2)	3 (4)	0.39

Data presented as number (percentage) of participants and compared using χ² test, except relative area reduction and estimated time to reach closure of the index plantar ulcer, which are presented as median (25th, 75th percentiles) and compared by using Wilcoxon test. P<0.05 was considered as significant.

*End points were assessed at 2-month visit in 13 participants for whom no data were available at 3-month visit in the ITT cohort analysis (see figure 2).

ITT, intention to treat; PP, per protocol.