Table 3.
Primary outcome results from 36 patients randomised to receive either NLFU + SOC or SOC alone. Results are shown for percentage and actual area reduction following 8 weeks of treatment. Values which have been adjusted for the influence of the covariate (wound area at the beginning of treatment) are shown alongside non‐adjusted values
| NLFU + SOC (n = 17) | SOC (n = 19) | Difference (95% CIs) | P‐value | |
|---|---|---|---|---|
| Adjusted (planned) | ||||
| Mean percentage change in wound area (%) | −46·6 (SD, 38·1) | −39·2 (SD, 38·0) | −7·4 (−33·4 to 18·6) | 0·565 |
| Actual change in wound area (cm2) | −6·2 (SD, 5·5) | −5·3 (SD, 5·5) | −0·9 (−4·7 to 2·9) | 0·618 |
| Non‐adjusted | ||||
| Percentage change in wound area (%) | −47·8 (SD, 40·3) | −38·2 (SD, 35·6) | −9·6 (−35·3 to 16·1) | 0·453 |
| Actual change in wound area (cm2) | −5·6 (SD, 6·6) | −5·8 (SD, 6·2) | 0·1 (−4·2 to 4·5) | 0·954 |
CI, confidence interval; NLFU, non‐contact low frequency ultrasound; SD, standard deviation; SOC: standard of care.