Table 2. Primary and Secondary Outcomesa.
| Outcome | Patient group | OR (95% CI) | P value | |
|---|---|---|---|---|
| ON101 (n = 122) | Absorbent dressing (n = 114) | |||
| Complete healing, No. (%) | ||||
| FAS | 74 (60.7) | 40 (35.1) | 2.84 (1.66-4.84) | <.001b |
| mITT | 73 (61.9) | 38 (33.9) | 3,15 (1.82-5.43) | <.001b |
| Secondary | ||||
| Change in WSA from baseline to visit 10, mean (SD), % | −78.0 (42.6) | −78.0 (34.9) | NA | .89 |
| Incidence of patients with 50% reduction in WSA on visit 10, No. (%) | 101 (82.8) | 98 (86.0) | 0.80 (0.39-1.62) | .53b |
| Incidence of wound infection | 6 (4.9) | 7 (6.1) | NA | .78 |
| Ulcer recurrence, No. (%)c | 15 (20.3) | 7 (17.5) | NA | .81 |
| Safety | ||||
| Patients with TEAEs, No. (%) | 76 (62.3) | 77 (67.5) | NA | .42 |
| No. of TEAEs | 207 | 235 | NA | |
| Related TEAEs | ||||
| Patients, No. (%) | 7 (5.7) | 5 (4.4) | NA | .77 |
| No. of events | 11 | 5 | NA | NA |
| Serious TEAEs | ||||
| Patients, No. (%) | 14 (11.5) | 9 (7.9) | NA | .39 |
| No. of events | 24 | 14 | NA | NA |
| Related serious TEAEs in events, No. (%) | 0 | 1 (0.9) | NA | <.48 |
| TEAE leading to death, No. | 0 | 0 | NA | NA |
| Subgroup analysis | ||||
| Wound closure, No./total No. (%) | ||||
| HbA1c level | ||||
| <9% | 59/90 (65.6) | 33/82 (40.2) | 2.81 (1.50-5.26) | <.001b |
| ≥9% | 15/32 (46.9) | 7/32 (21.9) | 3.14 (1.04-9.50) | .04b |
| Ulcer size, cm2 | ||||
| 1-5 | 55/88 (62.5) | 31/77 (40.3) | 2.46 (1.31-4.61) | .005b |
| >5 | 18/33 (54.5) | 8/36 (22.2) | 4.09 (1.42-11.80) | .009b |
| Ulcer duration, mo | ||||
| <6 mo | 62/86 (72.1) | 36/79 (45.6) | 3.07 (1.59-5.95) | <.001b |
| ≥6 mo | 12/36 (33.3) | 4/35 (11.4) | 3.99 (1.09-14.63) | .04b |
Abbreviations: FAS, full-analysis set; HbA1c, glycated hemoglobin; mITT, modified intent-to-treat; NA, not applicable; OR, odds ratio; TEAEs, treatment-emergent adverse events; WSA, wound (ulcer) surface area.
a
The absorbent dressing used was Hydrofiber (ConvaTec Ltd).
b
Calculated using a logistic regression model. Treatment was the main exposure variable; the baseline wound size in cm2 and Wagner grade were covariates.
c
Ulcer recurrence was recorded once the ulcer had healed completely and was observed during the follow-up period.