| Baseline (T0) | Weekly treatment | Evaluation at 3 months (T1) | Weekly treatment (if necessary) | Evaluation at 6 months (T2) | Evaluation at 12 months (T3) |
---|---|---|---|---|---|---|
Sociodemographic data | X | Â | Â | Â | Â | Â |
Ankle/arm index | X | Â | Â | Â | Â | Â |
Nutritional study | X | Â | Â | Â | Â | Â |
Localization of ulcer(s) | X | Â | X | Â | X | X |
Area of main ulcer | X | X | X | X | X | X |
Duration of the main ulcer | X | Â | Â | Â | Â | Â |
Exudate culture (if necessary) | X | X | X | X | X | X |
Changes in the size of the main ulcer | Â | X | X | X | X | X |
Characteristics of the main ulcer | X | X | X | X | X | X |
Complete healing (date) | Â | X | X | X | X | X |
Pain intensity | Â | X | X | X | X | X |
SF-12 | X | Â | X | Â | X | X |
Adverse events/effects | Â | X | X | X | X | X |
Compliance with hygiene-posture recommendations | X | Â | X | Â | X | X |
Location of treatment (clinic/home) | Â | X | Â | X | Â | Â |
Time employed in treatment | Â | X | Â | X | Â | Â |
Materials employed in treatment | Â | X | Â | X | Â | Â |
Number of needles used(Group A) | Â | X | Â | X | Â | Â |
Obtention of Deqi (Group A) | Â | X | Â | X | Â | Â |