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

East-Tallinn Central Hospital Department of Rheumatology

18 Ravi
Tallin, 11312

from

Tallin,