Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01891760 | Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers | PHASE3 | COMPLETED | 225 | — | — | May 1, 2010 | Jun 1, 2012 | Aug 21, 2013 | 28 | United States, Estonia +4 |
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold |
| Reference Therapy | ACTIVE_COMPARATOR | Profore - Four-layer compression bandaging therapy |
| Name | Type | Description |
|---|---|---|
| Dermagraft | DEVICE | Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum). |
| Profore | DEVICE | Four-layer compression bandaging therapy. |
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 com...