For the current study the primary outcome was the
prevalence of pain at time of healing. Prevalence was
defined as the percent of participants with pain at time of
healing. The secondary outcome was the incidence of pain
at time of healing. Incidence was defined as the percent of
participants with pain at time of healing of those who
were free of pain at treatment initiation. Pain specific to
the leg ulcer was assessed using the short form McGill
Pain Questionnaire (SF-MPQ) [30-32]. The McGill Pain
Questionnaire consists of 15 pain descriptors (11 sensory
and 4 affective), a visual analogue scale (VAS), and the
Present Pain Intensity (PPI). Each pain descriptor can be
valued either as “0=none”, “1=mild”, “2=moderate”, or
“3=severe”. For the purposes of the analysis values 1
through 3 were recoded as “1-3=present” versus “0=not
present”. From the descriptors, sensory, affective, and total
pain index scores were generated and standardized out of
100. The VAS is a 100mm scale anchored with “0=no
For the current study the primary outcome was the
prevalence of pain at time of healing. Prevalence was
defined as the percent of participants with pain at time of
healing. The secondary outcome was the incidence of pain
at time of healing. Incidence was defined as the percent of
participants with pain at time of healing of those who
were free of pain at treatment initiation. Pain specific to
the leg ulcer was assessed using the short form McGill
Pain Questionnaire (SF-MPQ) [30-32]. The McGill Pain
Questionnaire consists of 15 pain descriptors (11 sensory
and 4 affective), a visual analogue scale (VAS), and the
Present Pain Intensity (PPI). Each pain descriptor can be
valued either as “0=none”, “1=mild”, “2=moderate”, or
“3=severe”. For the purposes of the analysis values 1
through 3 were recoded as “1-3=present” versus “0=not
present”. From the descriptors, sensory, affective, and total
pain index scores were generated and standardized out of
100. The VAS is a 100mm scale anchored with “0=no
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