Phase 3
N=537
Pivotal Trial of Dermagraft(R) to Treat Venous Leg Ulcers
Venous Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT00909870 ↗Enrolled (actual)
537
Serious AEs
9.7%
Results posted
Feb 2013
Primary outcome: Primary: Complete Healing of the Study Ulcer by Week 16. — 201; 176 participants — p=0.1030
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dermagraft(R) (Device); Profore (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organogenesis
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Healing of the Study Ulcer by Week 16. |
201; 176 | 0.1030 |
| SECONDARY Time-to-Complete Healing |
58; 64 | 0.4046 |
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.
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.
- 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
Data sourced from ClinicalTrials.gov (NCT00909870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.