Venous Leg Ulcer
Conditions
Brief summary
* 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)
Interventions
DEVICEDermagraft
Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
DEVICEProfore
Four-layer compression bandaging therapy.
Sponsors
Shire Regenerative Medicine, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has completed study ABH-Dermagraft-001-08 2. Subject understands study requirements 3. Subject is available to participate in the 1 year-long observational follow-up.
Exclusion criteria
1. Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion 2. Subject is not available for the 1 year-long observational period. 3. Subject has any condition(s) which seriously compromises the subject's ability to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of study ulcer recurrence | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of complete study ulcer healing | 1 year |
| Incidence of study ulcer infection-related events | 1 year |
| Time to study ulcer recurrence | 1 year |
| Change in ulcer size | 1 year |
| Time to study ulcer healing | 1 year |
Countries
Estonia, Germany, Poland, South Africa, United Kingdom, United States
Outcome results
None listed