Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers

Completed · Phase 3

Conditions studied: Venous Leg Ulcer

In brief

This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.

Key facts

Study ID

NCT00909870

Run by

Organogenesis

People needed

537

Starts

2009-06-01

Expected to finish

2011-08-01

Last updated by the study team

2018-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >18 years of age
• ABI > 0.80
• Three or fewer venous leg ulcers, if multiple must be separated by 2 cm
• Ultrasound demonstrates venous reflux >0.5 seconds
• Study wound present for 1-24 months
• Study wound 2-15 sq cm surface area
• Clean, granulating wound
• Patient able and willing to sign informed consent and comply with study procedures.
• Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.

You may not qualify if…

• Wound etiology uncertain or not from venous hypertension.
• BMI>40
• Acute or chronic infectious skin disease
• Allergy or intolerance to Profore(R)
• Wound infection, cellulitis, osteomyelitis
• >2 weeks' treatment with immunosuppressive agents in recent past
• Investigational drug use within 30 days
• Severe malnutrition, drug and/or alcohol abuse
• Malignant disease unless in remission for 5 years
• History of radiation at the study site
• Other conditions that could impede wound healing
• Known history of HIV or AIDS
• Prior participation in any Dermagraft study
• Treatment with other bioengineered tissue products within 30 days
• Unable to understand the aims and objectives of the trial
• Inability to comply with study protocol
• NYHA Class III or IV CHF
• Uncontrolled diabetes mellitus
• Dorsal foot ulcer

Where it is running

• Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Southern Arizona VA Health Care System (SAVAHCS) — Tucson, Arizona, United States
• University of Arizona College of Medicine — Tucson, Arizona, United States
• Dr. Jagpreet S. Mukker — Fresno, California, United States
• VA Northern California Health Care System — Mather, California, United States
• Sutter Roseville Medical Center Wound Care Center — Roseville, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• General Vascular Surgery Group — San Leandro, California, United States
• Pacific Wound Center — Stockton, California, United States
• North American Center for Limb Preservation — New Haven, Connecticut, United States
• Providence Hospital — Washington D.C., District of Columbia, United States
• Foot & Ankle Associates of Florida — Altamonte Springs, Florida, United States
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States
• Comprehensive Wound Healing Center — Clearwater, Florida, United States
• Osceola Regional Wound Care Center — Kissimmee, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Doctor's Research Network — South Miami, Florida, United States
• Robert Snyder, DPM, CWS — Tamarac, Florida, United States
• Aiyan Diabetes Center — Evans, Georgia, United States
• Broadlawns Medical Center — Des Moines, Iowa, United States
• Boston Medical Center, Department of Vascular Surgery — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Covenant Wound Healing Center — Saginaw, Michigan, United States
• Coastal Clinical Research, Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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