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

Status:	Completed
Conditions:	Other Indications, Cardiology, Gastrointestinal
Therapuetic Areas:	Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:	No
Age Range:	18 - Any
Updated:	10/14/2017
Start Date:	May 2010
End Date:	June 2012

A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial

- 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)

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

We found this trial at

sites

North Amercian Center for Limb Preservation

New Haven, Connecticut 06515

from

New Haven, CT