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

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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

  • Subject has completed study ABH-Dermagraft-001-08
  • Subject understands study requirements
  • Subject is available to participate in the 1 year-long observational follow-up.

Exclusion criteria

  • Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion
  • Subject is not available for the 1 year-long observational period.
  • 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)

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

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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