* Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study. * Study Hypothesis: N/A (Long-term follow-up study)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
Four-layer compression bandaging therapy.
The incidence of study ulcer recurrence
Time frame: 1 year
Incidence of complete study ulcer healing
Time frame: 1 year
Incidence of study ulcer infection-related events
Time frame: 1 year
Time to study ulcer recurrence
Time frame: 1 year
Change in ulcer size
Time frame: 1 year
Time to study ulcer healing
Time frame: 1 year
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