Table 3.
Baseline and 4 Weeks Outcome Comparison Within and Between Both Groups.
| IG (n =
16) |
CG (n =
17) |
||||||
|---|---|---|---|---|---|---|---|
| BL | 4W | Time effect P-value (effect size) | BL | 4W | Time effect P-value (effect size) | Time ×Group effect P-value (effect size) | |
| Primary outcomes | |||||||
| Wound | |||||||
| Wound area (cm2) | 7.4 ± 8.5 | 5.8 ± 8.0 | 0.002 (0.20) | 3.1 ± 5.6 | 3.2 ± 8.7 | 0.928 (0.01) | 0.098 |
| Speed of wound healing (%) | 35.1 ± 36.6 | NA | 22.0 ± 58.2 | NA | 0.423 (0.28) | ||
| Daily speed of wound healing (%) | 1.3 ± 1.5 | NA | 0.8 ± 2.0 | NA | 0.440 (0.27) | ||
| Wound depth (mm) | 3.0 ± 2.1 | 1.8 ± 1.4 | 0.020 (0.51) | 3.2 ± 2.4 | 3.3 ± 4.2 | 0.865 (0.04) | 0.167 |
| Speed of wound depth healing (%) | 23.5 ± 52.5 | NA | 0.8 ± 79.2 | NA | 0.372 (0.34) | ||
| Daily speed of wound depth healing (%) | 0.9 ± 2.0 | NA | 0.1 ± 2.6 | NA | 0.349 (0.36) | ||
| Vascular | |||||||
| SPP (mmHg) | 71.0 ± 12.2 | 65.1 ± 19.1 | 0.216 (0.48) | 78.1 ± 18.6 | 72.2 ± 18.1 | 0.249 (0.24) | 0.644 |
| SPP subgroup mod./severe PAD (mmHg) | 76.0 ± 8.4 | 69.2 ± 23.7 | 0.466 (0.47) | 77.0 ± 23.6 | 67.3 ± 11.6 | 0.333 (0.44) | 0.984 |
| Secondary outcomes | |||||||
| Vascular | |||||||
| SatO2 (%) | 69.3 ± 21.3 | 72.3 ± 21.5 | 0.547 (0.15) | 73.1 ± 13.5 | 73.9 ± 12.1 | 0.810 (0.07) | 0.731 |
| SatO2 subgroup mod./severe PAD (%) | 47.3 ± 20.1 | 63.3 ± 22.3 | 0.015 (0.83) | 61.0 ± 13.7 | 70.1 ± 9.9 | 0.087 (0.83) | 0.419 |
| Neuropathic | |||||||
| VPT (Volts) | 25.6 ± 7.2 | 20.2 ± 14.0* | 0.245 (0.16) | 25.9 ± 17.8 | 32.1 ± 9.2* | 0.110 (0.53) | 0.049 |
| VPT subgroup mod./severe PAD (Volts) | 32.1 ± 18.9 | 17.1 ± 10.4* | 0.149 (0.39) | 19.8 ± 21.4 | 31.7 ± 16.5* | 0.099 (0.37) | 0.021 |
Values are presented as mean ± standard deviation (SD) or n (%).
Abbreviations: NA: not applicable; SatO2: tissue oxygen saturation; SPP: skin perfusion pressure; VPT: vibration perception threshold.
*
Values of VPT were reported at week; Effect size values represent Cohen’s d effect size.