Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Leg UlcerVaricose Ulcer
Interventions
DEVICE

Celaderm (Frozen Cultured Epidermal Allograft)

Four biweekly applications of Celaderm plus compression therapy

DEVICE

Celaderm (Frozen Cultured Epidermal Allograft)

Four weekly applications of Celaderm plus compression therapy

DEVICE

Control (compression bandaging)

Multi-layer compression bandaging

Trial Locations (9)

10461

Center for Curative & Palliative Wound Care, Calvary Hospital, The Bronx

11794

State University of New York Stony Brook, Stony Brook

16602

Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic, Altoona

27599

University of North Carolina at Chapel Hill, Division of Vascular Surgery, Durham

33321

Dr. Robert Snyder, Tamarac

60714

National Center for Limb Preservation, Niles

78205

Peripheral Vascular Associates, P.A., San Antonio

84770

Dixie Regional Medical Center, Wound Care, St. George

02215

Beth Israel Deaconess Medical Center, Division of Podiatry, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY