Long-Term Follow-Up to the DEVO Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers (LTFU)

Shire

Status and phase: Completed; Phase 3

Conditions: Venous Leg Ulcer

Treatments: Device: Dermagraft; Device: Profore

Study type: Interventional

Funder types: Industry

Identifiers

NCT01891760

ABH-Dermagraft-001-09

Details and patient eligibility

About

• 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)

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Treatment

Experimental group

Description:

Dermagraft - Allogenic Neonatal Dermal Fibroblasts Seeded on poly(glycolide-co-L-lactide)(PGLLA)Scaffold

Treatment:

Device: Dermagraft

Reference Therapy

Active Comparator group

Description:

Profore - Four-layer compression bandaging therapy

Treatment:

Device: Profore