Table 1.
Patient demographics and other baseline characteristics
| Parametera,b | DETP n = 138 | Placebo n = 136 | P value |
|---|---|---|---|
| Age (years) | 34.5 ± 13.6 (18–65) |
33.3 ± 12.3 (18–62) |
0.42 |
| Height (cm) | 171.5 ± 8.9 (150–197) |
170.0 ± 8.7 (143–188) |
0.14 |
| Weight (kg) | 70.1 ± 12.8 (45–105) |
67.4 ± 15.7 (38–168) |
0.13 |
| Body mass index (kg/m2) | 23.8 ± 3.9 (16.9–39.4) |
23.2 ± 4.2 (16.5–52.4) |
0.23 |
| Sex | |||
| Male | 79 (57%) | 70 (51%) | 0.34 |
| Female | 59 (43%) | 66 (49%) | |
| Injury characteristics | |||
| Time to injury (hours) | 17.7 ± 11.4 (1–48) |
19.3 ± 11.7 (0.5–48) |
0.28 |
| Injury location | |||
| Right ankle | 84 (61%) | 73 (54%) | 0.26 |
| Left ankle | 54 (39%) | 62 (46%) | |
| Swelling (mm)c | 14.5 ± 10.6 (−10–50) |
16.9 ± 11.0 (0–60) |
0.09 |
| Functional impairment, n (%) | |||
| None | 2 (1%) | 3 (2%) | 0.06 |
| Mild | 39 (29%) | 26 (19%) | |
| Moderate | 62 (45%) | 60 (44%) | |
| Severe | 34 (25%) | 47 (34%) | |
| Leaning on single injured foot, n (%) | |||
| Possible without pain | 9 (7%) | 10 (7%) | 0.79 |
| Possible with pain | 102 (74%) | 96 (71%) | |
| Not possible | 27 (19%) | 30 (22%) | |
| Skin examination | |||
| Normal | 134 (97%) | 133 (98%) | 0.72 |
| Abnormal (erythema/abrasion) | 4 (3%) | 3 (2%) | |
| Mean pain score (VAS) (mm) | 67.0 ± 10.6 (50–92) |
69.3 ± 11.0 (50–100) |
0.08 |
Notes:
a
Data were pooled from Study 1 and Study 2;
b
Mean ± standard deviation (ranges) for continuous variables; number of patients with percentage of total in parenthesis for categorical variables. P values derived from analysis of variance or the Chi-square test.
c
Difference in mm between the submalleolar perimeter of the injured and healthy ankle.
Abbreviations: DETP, diclofenac epolamine topical patch; VAS, visual analog scale.