Table 1

Outcome measures. Work scheme with description of assessment visits and times.

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




Ankle/arm index
 X




Nutritional study
 X




Localization of ulcer(s)
 X
X
X
 X
Area of main ulcer
 X
 X
 X
 X
 X
 X
Duration of the main ulcer
 X




Exudate culture (if necessary)
 X
 X
 X
 X
 X
 X
Changes in the size of the main ulcer
X
 X
 X
 X
 X
Characteristics of the main ulcer
 X
 X
 X
 X
 X
 X
Complete healing (date)
X
 X
 X
 X
 X
Pain intensity
X
 X
 X
 X
 X
SF-12
 X
X
X
 X
Adverse events/effects
X
 X
 X
 X
 X
Compliance with hygiene-posture recommendations
 X
X
X
 X
Location of treatment (clinic/home)
X
X

Time employed in treatment
X
X

Materials employed in treatment
X
X

Number of needles used(Group A)
X
X

Obtention of Deqi (Group A)
X
X

Vas et al. BMC Complementary and Alternative Medicine 2008 8:29   doi:10.1186/1472-6882-8-29