Table 1.
Visit times and data collection
|
Data collection |
-1 week |
0 week |
4 weeks |
8 weeks |
1 month after treatment phase |
|---|---|---|---|---|---|
| Baseline | Treatment phase | Follow-up phase | |||
|
Patients |
|
|
|
|
|
| Informed consent |
× |
|
|
|
|
| Sign the informed consent |
|
× |
|
|
|
| Medical history |
× |
|
|
|
|
| Physical examination |
× |
|
|
|
|
| Randomization |
|
× |
|
|
|
|
Intervention |
|
|
|
|
|
| EA group (n = 18) |
|
40 sessions of EA; plus standard wound care |
|
||
|
Comparison |
|
|
|
|
|
| Control group (n = 18) |
|
40 sessions of standard wound care |
|
||
|
Outcomes |
|
|
|
|
|
| WSA |
|
× |
× |
× |
× |
| VAS |
|
× |
× |
× |
× |
| PUHTP |
|
× |
× |
× |
× |
|
Safety |
|
|
|
|
|
| Adverse events | × | × | × | × | |
EA, electroacupuncture; PUHTP, proportion of ulcers healed within trial period; VAS, visual analogue scale; WSA, wound surface area; the symbol ‘x’ is used as a check mark.