Table 2.
Wound‐ and patient‐related variables between groups at randomisation. Continuous variables are reported as means and SDs and categorical variables as number (n) and percentage (%)
| Variable | dHACA | SOC | P |
|---|---|---|---|
| Age (y) | 60.1 (11.77) | 61.0 (10.66) | .71 |
| Race | |||
| Caucasian | 38 (95) | 37 (93) | .60 |
| African American | 2 (5) | 2 (5) | |
| Hispanic | 0 (0) | 1 (2) | |
| Gender | |||
| Male | 23 (58) | 31 (78) | .056 |
| Female | 17 (42) | 9 (22) | |
| Body Mass Index (BMI) | 34.0 (9.30) | 34.5 (9.42) | .83 |
| Smoker | 4 (10) | 3 (8) | 1.0 |
| Drinks alcohol | 8 (20) | 8 (20) | 1.0 |
| HbA1c | 7.6 (1.47) | 7.9 (1.48) | .36 |
| Creatinine | 1.1 (0.44) | 1.1 (0.40) | .52 |
| Initial wound area (cm2) | 2.1 (1.46); median: 1.6 | 3.1 (3.58); median: 1.8 | .15 |
| Wound plantar surface | 29 (73) | 30 (10) | .80 |
| Wound location | |||
| Toe | 10 (25) | 9 (23) | .69 |
| Forefoot | 16 (40) | 14 (35) | |
| Midfoot | 12 (30) | 12 (30) | |
| Heel/ankle/hindfoot | 2 (5) | 5 (12) | |
dHACA, dehydrated human amnion and chorion allograft; SOC, standard of care.
Average of HbA1c values (beginning and end of study).