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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00270972

Enrollment

Registered

2005-12-29

Start date

2005-09-30

Completion date

Unknown

Last updated

2006-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leg Ulcer, Venous Insufficiency

Keywords

Venous leg ulcer, Venous insufficiency, OrCel

Brief 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.

Interventions

DEVICEBilayered Cellular Matrix (OrCel)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Any race, between 18 and 85 years of age * Male or female * Chronic venous insufficiency * Ulcer size between 2 and 20 sq cm, inclusive * Ulcer present for at least one month * ABI \>0.7

Exclusion criteria

* Decrease in wound size \>35% during Screening Phase * Infection at ulcer site * Uncontrolled diabetes mellitus * Malnutrition * Previous treatment with excluded medications

Design outcomes

Primary

Measure	Time frame
Investigator Assessment of wound healing	—

Secondary

Measure	Time frame
Planimetric assessment of wound healing	—
Photographic assessment of wound healing	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026