Table 4

Primary, secondary and safety study outcomes

CohortConventional groupOrthèse DiabèteP value
Primary outcome
Blinded assessment of wound closure of the index plantar ulcer at the 3-month visit*ITT19 (33)19 (35)0.79
Blinded assessment of wound closure of the index plantar ulcer at the 3-month visitPP18 (34)17 (37)0.76
Secondary outcomes
Closure of the index plantar ulcer
 1-month visitITT4 (7)9 (17)0.11
 2-month visitITT15 (26)17 (31)0.51
 6-month visitITT28 (48)31 (57)0.33
Closure of all initial plantar ulcers
 1-month visitITT4 (7)8 (15)0.19
 2-month visitITT12 (21)13 (24)0.82
 3-month visitITT17 (30)18 (33)0.84
 6-month visitITT24 (42)23 (43)0.96
Relative area reduction of the index plantar ulcer (%)
 1-month visitITT63 (52 to 74)58 (47 to 70)0.56
 2-month visitITT76 (67 to 85)77 (68 to 87)0.88
 3-month visitITT85 (76 to 94)85 (76 to 94)0.96
 6-month visitITT87 (79 to 94)92 (85 to 99)0.33
Estimated time to reach closure of the index plantar ulcer (days)ITT81 (61 to 102)85 (66 to 103)0.80
New plantar ulcerITT14 (25)14 (27)0.82
Ipsilateral limb-amputationITT2 (4)5 (10)0.20
Infectious complicationITT8 (14)7 (13)0.68
Safety
Any adverse eventsSafety16 (28)19 (28)0.97
Any serious adverse eventsSafety41 (72)48 (72)0.97
Any adverse events related to offloading deviceSafety2 (4)10 (15)0.03
Adverse events leading to discontinuationSafety03 (4)0.11
All-cause hospitalizationSafety23 (40)18 (27)0.11
DeathSafety1 (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.