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

Organogenesis

Status and phase: Completed; Phase 3

Conditions: Venous Leg Ulcer

Treatments: Device: Dermagraft(R); Device: Profore

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909870

ABH-Dermagraft-001-08

Details and patient eligibility

About

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.

Enrollment: 537 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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537 participants in 2 patient groups

1

Experimental group

Description:

Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.

Treatment:

Device: Dermagraft(R)

2

Active Comparator group

Description:

Weekly application of compression dressings only, in combination with systematic surgical wound debridement.

Treatment:

Device: Profore