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

Phase 3

Completed

• Conditions: Venous Leg Ulcer

• Registration Number: NCT00909870
• Lead Sponsor: Organogenesis

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-05-29
• Study Start: 2009-06
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Disposition First Submitted: 2012-09-18
• Disposition First Submitted QC: 2012-09-18
• Disposition First Posted: 2012-09-25
• Results First Submitted: 2012-12-31
• Results First Submitted QC: 2012-12-31
• Results First Posted: 2013-02-04
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 537

Inclusion Criteria

• >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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete Healing of the Study Ulcer by Week 16.	16 weeks

Secondary Outcome Measures

Name	Time	Method
Time-to-Complete Healing	From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days.	Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.

Trial Locations

Locations (70)

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

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

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