Trials / Unknown
UnknownNCT00270972
The Evaluation of OrCel for the Treatment of Venous Ulcers
A Confirmatory Study to Evaluate the Safety and Efficacy of Cryopreserved Bilayered Cellular Matrix (ORCEL) for the Treatment of Venous Ulcers
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (planned)
- Sponsor
- Ortec International · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This study was designed to confirm the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care are compared to standard care alone. Standard care consists of currently accepted compression therapy. Patients are treated for 12 weeks. Patients with healed ulcers are followed for an additional 12 weeks to assess durability of the healed wound.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bilayered Cellular Matrix (OrCel) |
Timeline
- Start date
- 2005-09-01
- First posted
- 2005-12-29
- Last updated
- 2006-06-05
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00270972. Inclusion in this directory is not an endorsement.