Venous leg ulcers MedDRA version: 9.1 Level: LLT Classification code 10024134 Term: Leg ulcer (exc varicose)
Conditions
Interventions
Product Name: Dermagraft
Product Code: NA
Pharmaceutical Form: Living tissue equivalent
Sponsors
Advanced BioHealing Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 follow-up. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary exploratory objective of this study is to observe the long-term (1 year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed ABH-DERMAGRAFT-001-08: a prospective, multi-center, randomized, controlled clinical investigation of Dermagraft in subjects with venous leg ulcers. ;Secondary Objective: A secondary exploratory objective will be the incidence of complete study ulcer healing (defined as 100% epithelialization, with no evidence of drainage or scab) over the 1-year observational period for all study ulcers not healed at the time of study enrollment. Additional secondary measures will be the incidence of study ulcer infection-related events, time to study ulcer recurrence, change in ulcer size, and time to study ulcer healing. ; Primary end point(s): The primary outcome measure will be the incidence of study ulcer recurrence (defined as a full-thickness skin ulcer, secondary to venous insufficiency, located in approximately the same anatomical location as the study ulcer that previously achieved complete re-epithelialization under treatment in ABH-DERMAGRAFT-001-08) during the 1-year observational period. This primary outcome will be evaluated only on subjects from each cohort who entered the 1-year follow-up period with a healed ulcer. | — |
Countries
Estonia, Germany, United Kingdom
Outcome results
None listed