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

Shire Regenerative Medicine, Inc.0 个研究点目标入组 180 人开始时间: 2010年6月23日最近更新: 2012年8月21日

适应症

试验速览

暂无简介。

•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

•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.

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