NCT01327937View on ClinicalTrials.gov

A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

December 31, 2013

Conditions
Venous Ulcer
Interventions
DEVICE

Apligraf

Apligraf group - Applied at Day 0, Weeks 1-4 (maximum of 5 applications) Also cross-over at Week 4 for Control NPTH group - Apligraf applied at Week 4, Weeks 5-8 (maximum of 5 applications)

OTHER

Standard of Care Dressing Group

Standard dressing regimen - Foam dressing (eg, Mepilex) and 4 layered compression system (eg, Profore)

Trial Locations (1)

33136

University of Miami, Miami

Sponsors

Lead Sponsor

Organogenesis
All Listed Sponsors
lead

Organogenesis

INDUSTRY

NCT01327937 - A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg Ulcers | Biotech Hunter | Biotech Hunter