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

NCT00909870·70 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

Organogenesis

Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible 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 be 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

The record

StatusCompleted

PhasePhase 3

Taking part537

StartedJun 2009

UpdatedJun 18, 2018

Conditions

Venous Leg Ulcer

Where70

Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States

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