A Prospective, Multi-Center, Randomized, Controlled Clinical Investigation of Dermagraft(R) in Subjects With Venous Leg Ulcers DEVO-Trial

Organogenesis70 sites in 5 countries537 target enrollmentJune 2009

ConditionsVenous Leg Ulcer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Venous Leg Ulcer
Sponsor: Organogenesis
Enrollment: 537
Locations: 70
Primary Endpoint: Complete Healing of the Study Ulcer by Week 16.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

August 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organogenesis

Responsible Party

Sponsor

Eligibility Criteria

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.
•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

Outcomes

Primary Outcomes

Complete Healing of the Study Ulcer by Week 16.

Time Frame: 16 weeks

Secondary Outcomes

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.)