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

• Conditions: Venous leg ulcers; MedDRA version: 9.1Level: LLTClassification code 10024134Term: Leg ulcer (exc varicose)

• Registration Number: EUCTR2010-019887-35-DE
• Lead Sponsor: Advanced BioHealing Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-28
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1.Subject has completed ABH-DERMAGRAFT-001-08, up to and including the final visit, Visit #23 - Week 28, with the following exception:
-If subject is part of the Control cohort, and the study ulcer under observation in ABH-DERMAGRAFT-001-08 is not healed at the Week 16 (Visit # 19) visit, the subject is eligible for inclusion into this long-term study as early as Week 20 (Visit #21).
2.Subject understands study requirements and is available to participate in the 1 year-long observational followup. This includes an ability to correspond with the site for follow-up information and a willingness to attend scheduled clinic visits and unscheduled clinic visits in the event of an ulcer recurrence or other Adverse Events.
3.Subject has read and signed the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form before screening procedures are undertaken. The informed consent will be used in each country and will include all the required elements. Each informed consent will be translated into all
local languages for countries participating in the study and subjects will sign the informed consent in their own language.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects who withdrew or were terminated from ABH-DERMAGRAFT-001-08 before Visit #23 – Week 28. Additionally, any subjects who are not available for the 1 year-long observational period in this study are excluded.
2.Subjects who are unable to understand the aims and objectives of the trial.
3.Subject has any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor compliance with medical treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified