Dermagraft Follow-up
Research type
Research Study
Full title
A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects with Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial
IRAS ID
55929
Contact name
Keith Harding
Contact email
Sponsor organisation
Advanced BioHealing Inc
Eudract number
2010-019887-35
ISRCTN Number
0000000000000
Clinicaltrials.gov Identifier
0000000000000
Research summary
I would like to submit the enclosed protocol, ABH-Dermagraft-001-09, for ethics committee review. ABH-Dermagraft-001-09, is a Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects with Venous Leg Ulcers, and a Long-term follow-up to the Dermagraft-001-08 (09/MRE09/37) trial. The objective of this trial is to observe the long-term (12 months) outcomes of Dermagraft, together with four-layer compression bandaging therapy, in the treatment of venous leg ulcers, as compared with a conventional treatment of four-layer compression bandaging therapy alone. The study will be comprised of two prospective cohorts, of approximately 90 subjects each, for a total of 180 subjects. ABH-Dermagraft-001-09 is designed for subjects who previously participated in ABH-Dermagraft-001-08. Prospective subjects may have either healed or unhealed full thickness venous leg ulcers. Subjects who were previously in the control group of ABH-Dermagraft-001-08, whose wound has not healed, are eligible to receive up to eight weekly applications of Dermagraft. All subjects who participate in ABH-Dermagraft-001-09 will attend 6 bi-monthly clinic visits, and will participate in 6 bi-monthly phone calls (during the months where no clinic visit occurs). The study will last 12 months for each study subject.
REC name
Wales REC 3
REC reference
10/MRE09/16
Date of REC Opinion
6 Sep 2010
REC opinion
Further Information Favourable Opinion