Status:
COMPLETED
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Lead Sponsor:
Organogenesis
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- \>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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
537 Patients enrolled
Trial Details
Trial ID
NCT00909870
Start Date
June 1 2009
End Date
August 1 2011
Last Update
June 18 2018
Active Locations (70)
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1
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
2
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
3
HOPE Research Institute
Phoenix, Arizona, United States, 85050
4
Southern Arizona VA Health Care System (SAVAHCS)
Tucson, Arizona, United States, 85723